SCS - Paralysis Reports Thru May 2019

Primary word(s) count
spinal paralysis 681
Report ID Date of Event Date Manufacturer Received Report Date FDA Received Date Report Type
7911646 2018-09-19 2018-09-28 2018-10-04 2018-09-26 Injury
7575109 2017-05-18 2018-06-04 2018-06-06 2018-06-06 Malfunction

7439971 2015-08-20 2018-03-20 2018-04-18 2018-04-18 Injury
7431114 2017-12-11 2018-03-20 2018-04-13 2018-04-13 Death
6868327 2016-01-19 2017-09-13 2017-09-14 Injury
6433225 2017-02-24 2017-02-24 2017-02-24 2017-03-24 Injury
5588535 2016-03-23 2016-04-28 2016-03-25 2016-04-20 Death

5493422 2016-02-09 2016-03-10 2016-04-05 2016-03-10 Injury
5317969 2015-12-02 2015-12-02 2015-12-22 Injury
5276952 2015-12-01 2015-12-06 2015-12-06 Injury

4361608 2015-02-02 2014-12-03 2014-12-24 Injury
4255889 2015-01-27 2014-10-27 2014-11-17 Injury

4031402 2014-07-03 2014-11-07 2014-07-31 2014-08-22 Injury
3931353 2014-06-30 2014-06-30 2014-07-14 Injury
3301315 2013-10-04 2013-07-24 2013-08-21 Injury
3301327 2013-10-04 2013-07-24 2013-08-21 Injury

2652151 2012-06-14 2012-06-14 2012-06-14 2012-07-05 Death
2185457 2011-06-01 2015-05-29 2011-06-19 2011-07-12 Injury
1400814 2006-01-25 2006-01-26 2006-01-26 2009-06-11 Injury
8650298 2019-05-09 2019-05-10 2019-05-29 2019-05-29 Injury
8629886 2019-04-23 2019-04-23 2019-05-21 2019-05-21 Injury
8613809 2019-04-03 2019-04-17 2019-05-15 2019-05-15 Injury
8608530 2019-06-04 2019-06-06 2019-05-14 Injury
8608897 2019-03-28 2019-04-16 2019-05-14 2019-05-14 Injury
8584193 2019-03-25 2019-04-17 2019-05-06 2019-05-06 Injury
8579019 2019-04-11 2019-04-11 2019-05-03 2019-05-03 Injury

8537523 2019-04-19 2019-04-22 2019-04-22 Injury
8520749 2019-03-19 2019-04-16 2019-04-16 Injury
8489114 2019-03-15 2019-03-15 2019-04-05 2019-04-05 Injury
8458613 2019-02-28 2019-02-28 2019-03-27 2019-03-27 Injury
8444569 2019-02-15 2019-03-05 2019-03-22 2019-03-22 Injury

8436682 2018-07-01 2019-03-20 2019-03-20 2019-03-20 Injury
8343953 2019-02-13 2019-02-13 2019-02-15 2019-02-15 Malfunction
8301279 2019-01-12 2019-02-04 2019-02-04 Malfunction
8278972 2018-12-28 2018-12-27 2019-01-24 2019-01-25 Injury
8279220 2019-01-15 2019-01-16 2019-01-25 2019-01-25 Injury

8279413 2018-05-12 2019-01-08 2019-01-25 2019-01-25 Injury
8257345 2018-12-24 2018-12-24 2019-01-17 2019-01-17 Injury
8233643 2018-12-12 2018-12-13 2019-01-09 2019-01-10 Injury
8237030 2018-12-22 2019-01-10 2019-01-10 Injury
8209321 2018-12-15 2018-12-27 2019-01-16 2019-01-02 Injury
8204801 2018-12-13 2018-12-13 2018-12-28 2018-12-28 Injury
8200651 2018-10-18 2018-12-18 2018-12-27 2018-12-27 Injury
8192766 2018-09-27 2018-11-27 2018-12-21 2018-12-21 Injury
8185951 2018-10-31 2018-11-26 2018-12-20 2018-12-20 Malfunction
8138071 2015-08-28 2018-12-04 2018-12-05 Injury

8116833 2018-10-17 2018-11-26 2018-11-26 2018-11-29 Injury
8099851 2018-10-18 2018-11-07 2018-11-21 Injury

8072453 2018-10-18 2018-10-19 2018-11-14 2018-11-14 Injury
8047433 2018-11-06 2018-11-07 2018-11-07 Malfunction
8044780 2018-10-05 2018-10-09 2018-11-06 2018-11-06 Injury
8023736 2018-10-31 2018-11-12 2018-10-31 Malfunction
8019793 2018-10-26 2018-10-26 2018-10-30 2018-10-30 Injury
8015825 2018-10-09 2018-10-29 2018-10-29 Injury

7960861 2018-10-01 2018-11-02 2018-11-07 2018-10-12 Malfunction
7938994 2018-09-30 2018-10-10 2018-10-25 2018-10-05 Malfunction
7923222 2018-10-01 2018-10-10 2018-10-01 Malfunction
7920796 2018-09-25 2018-10-03 2018-10-17 2018-09-28 Injury
7904288 2018-08-25 2018-08-27 2018-09-24 2018-09-24 Injury
7897653 2018-09-20 2018-09-21 2018-09-28 2018-09-21 Injury
7822847 2018-08-01 2018-08-03 2018-08-28 2018-08-28 Injury
7783141 2018-07-20 2018-07-20 2018-08-14 2018-08-14 Injury
7728134 2018-06-29 2018-06-29 2018-07-27 2018-07-27 Injury

7677046 2018-07-01 2018-07-09 2018-07-11 2018-07-11 Malfunction
7674653 2018-06-14 2018-07-10 2018-07-10 Injury
7674681 2018-06-14 2018-06-14 2018-07-10 2018-07-10 Injury
7671043 2018-06-09 2018-06-11 2018-07-09 2018-07-09 Injury
7663824 2018-06-04 2018-06-08 2018-07-05 2018-07-05 Injury
7635019 2018-06-01 2018-06-21 2018-06-25 2018-06-25 Malfunction
7558456 2018-05-01 2018-05-10 2018-05-31 2018-05-31 Injury
7548951 2018-05-01 2018-05-24 2018-05-29 2018-05-29 Malfunction
7534428 2018-04-07 2018-04-23 2018-05-22 2018-05-22 Injury
7522263 2018-05-15 2018-05-17 2018-05-22 2018-05-17 Malfunction

7516049 2018-04-27 2018-04-28 2018-05-15 2018-05-15 Injury
7505276 2018-04-13 2018-04-13 2018-05-10 2018-05-10 Injury
7502488 2018-05-09 2018-05-09
7473773 2018-03-31 2018-04-04 2018-04-30 2018-04-30 Malfunction
7447027 2018-03-27 2018-03-28 2018-04-20 2018-04-20 Injury

7437980 2018-02-21 2018-03-20 2018-04-17 2018-04-17 Malfunction
7438303 2016-06-15 2018-03-19 2018-04-17 2018-04-17 Injury
7432593 2018-04-11 2018-04-11 2018-04-16 2018-04-16 Injury
7400352 2018-02-27 2018-04-02 2018-04-05 2018-04-05 Malfunction
7381846 2018-02-28 2018-02-28 2018-03-29 2018-03-29 Injury
7374927 2017-09-21 2018-03-21 2018-03-27 2018-03-27 Malfunction

7328929 2018-03-03 2018-03-07 2018-03-09 2018-03-09 Malfunction
7320506 2017-12-26 2018-02-10 2018-03-07 2018-03-07 Malfunction
7310258 2018-02-27 2018-03-21 2018-04-09 2018-03-02 Malfunction
7305823 2018-02-01 2018-02-26 2018-03-20 2018-03-01 Injury
7306507 2017-07-26 2018-02-27 2018-03-01 2018-03-01 Malfunction
7308019 2017-12-04 2017-12-12 2018-03-01 2018-03-01 Injury
7298182 2018-01-31 2018-01-31 2018-02-26 2018-02-26 Injury
7298542 2018-02-01 2018-02-01 2018-02-26 2018-02-26 Injury
7248038 2018-02-02 2018-02-05 2018-02-07 2018-02-07 Injury

7231020 2018-01-29 2018-01-29 2018-01-31 2018-01-31 Injury
7221667 2003-12-01 2018-01-23 2018-01-26 2018-01-26 Injury
7207386 2018-01-10 2018-01-19 2018-01-19 Injury
7203051 2018-01-04 2018-01-19 2018-01-30 2018-01-18 Injury
7200234 2017-09-24 2018-01-12 2018-01-16 Injury

7164114 2017-10-28 2017-12-28 2018-01-04 2018-01-04 Malfunction
7146978 2017-12-05 2017-12-06 2017-12-26 2017-12-26 Injury
7129103 2017-12-15 2017-12-19 2018-01-12 2017-12-19 Injury
7131415 2015-02-19 2017-11-29 2017-12-19 2017-12-19 Injury
7131424 2015-02-19 2017-11-29 2017-12-19 2017-12-19 Injury
7121355 2017-09-01 2018-01-17 2018-01-18 2017-12-15 Malfunction
7083057 2017-12-03 2017-12-03 2017-12-05 2017-12-05 Injury
7070387 2016-09-01 2017-11-28 2017-11-30 2017-11-30 Injury
7042561 2017-11-06 2017-11-21 2017-12-01 2017-11-17 Injury
7043258 2017-10-27 2017-10-27 2017-11-17 2017-11-17 Injury

7027672 2017-10-28 2017-10-30 2017-11-14 2017-11-14 Malfunction
7028331 2003-11-12 2017-11-30 2017-11-30 2017-11-14 Injury
7018712 2017-09-10 2017-11-08 2017-11-10 2017-11-10 Injury
6915561 2017-10-02 2017-10-03 2017-10-06 2017-10-05 Injury
6866520 2017-09-05 2017-09-29 2017-10-10 2017-09-14 Injury
6855786 2017-08-18 2017-08-19 2017-09-11 2017-09-11 Injury
6853747 2017-09-07 2017-09-07 2017-09-26 2017-09-08 Injury
6842904 2017-08-09 2017-08-09 2017-09-05 2017-09-05 Injury
6842916 2017-08-09 2017-08-09 2017-09-05 2017-09-05 Injury
6842933 2017-08-09 2017-08-09 2017-09-05 2017-09-05 Injury
6816703 2010-04-12 2017-08-22 2017-08-24 2017-08-24 Injury

6796023 2017-07-24 2017-07-24 2017-07-24 2017-08-15 Injury
6770144 2017-07-01 2017-08-04 2017-08-07 2017-08-07 Malfunction
6757581 2017-07-07 2017-07-10 2017-07-10 2017-08-01 Injury
6745907 2017-07-06 2017-07-06 2017-07-06 2017-07-26 Injury
6725554 2017-06-26 2017-07-19 2017-07-19 Injury
6720934 2017-06-20 2017-06-22 2017-07-18 2017-07-18 Malfunction
6728964 2016-08-24 2017-07-18 2017-07-18 Injury
6689229 2017-06-12 2017-07-06 2017-07-06 Injury
6690092 2017-05-08 2017-06-12 2017-07-06 2017-07-06 Malfunction
6648129 2013-01-01 2017-06-14 2017-06-16 2017-06-16 Malfunction

6629531 2017-06-05 2017-06-09 2017-06-09 Malfunction
6616888 2016-11-01 2017-05-10 2017-06-06 2017-06-06 Malfunction
6613212 2017-05-15 2017-05-15 2017-06-05 2017-06-05 Injury
6588236 2017-04-25 2017-04-25 2017-04-25 2017-05-24 Injury
6585722 2017-05-02 2017-05-02 2017-05-02 2017-05-23 Injury
6578887 2017-04-26 2017-04-26 2017-04-26 2017-05-19 Injury
6571392 2017-04-06 2017-04-21 2017-04-21 2017-05-16 Injury
6523728 2017-03-28 2017-04-03 2017-04-26 2017-04-26 Injury
6517404 2017-03-31 2017-04-24 2017-04-24 Injury
6503390 2017-03-31 2017-03-31 2017-04-19 2017-04-19 Injury
6477669 2016-01-01 2017-04-01 2017-04-10 2017-04-10 Malfunction

6473556 2017-03-13 2017-03-15 2017-04-07 2017-04-07 Injury
6460638 2017-02-17 2017-04-20 2017-05-05 2017-04-05 Injury
6437303 2017-03-08 2017-03-08 2017-03-08 2017-03-27 Injury
6423056 2017-03-23 2017-02-27 2017-03-21 Injury
6358633 2016-09-14 2017-01-30 2017-01-30 2017-02-24 Injury

6346072 2017-02-16 2017-02-17 2017-02-21 2017-02-21 Injury
6348174 2017-01-28 2017-01-28 2017-01-28 2017-02-21 Injury
6313186 2017-01-12 2017-01-18 2017-01-18 2017-02-08 Injury
6307532 2016-11-17 2017-01-18 2017-01-18 2017-02-07 Injury
6307533 2016-11-17 2017-01-18 2017-01-18 2017-02-07 Injury
6295026 2017-01-06 2017-01-10 2017-01-10 2017-02-01 Injury

6271015 2016-09-01 2017-01-12 2017-01-23 2017-01-23 Injury
6266650 2016-12-28 2016-12-28 2017-01-20 Injury
6263764 2016-12-19 2016-12-29 2017-01-19 2017-01-19 Injury
6244053 2017-01-07 2017-01-09 2017-01-11 2017-01-11 Malfunction
6233195 2016-12-15 2016-12-17 2016-12-17 2017-01-09 Injury
6226929 2016-12-12 2017-01-16 2017-01-16 2017-01-05 Injury
6226939 2016-12-12 2017-01-16 2017-01-16 2017-01-05 Injury
6224141 2016-12-21 2017-01-10 2016-12-21 2017-01-04 Injury
6212598 2016-12-01 2016-12-05 2016-12-29 2016-12-29 Injury
6214695 2016-12-05 2017-01-10 2017-01-10 2016-12-29 Injury

6214709 2016-12-05 2017-01-10 2017-01-10 2016-12-29 Injury
6207669 2015-09-25 2017-01-06 2016-12-12 2016-12-27 Injury
6187707 2016-08-30 2016-12-02 2016-12-02 2016-12-19 Injury
6169581 2016-11-17 2016-11-17 2016-11-17 2016-12-13 Injury
6172266 2016-11-21 2016-11-21 2016-12-13 Injury

6165752 2013-01-24 2016-12-13 2017-01-03 2016-12-12 Injury
6152954 2016-11-05 2016-11-17 2016-11-17 2016-12-07 Injury
6137387 2016-11-02 2016-11-04 2016-11-04 2016-12-01 Injury
6128472 2016-11-12 2016-11-21 2016-11-28 2016-11-28 Malfunction

6121120 2016-08-17 2016-11-29 2016-12-02 2016-11-22 Injury
6113389 2016-11-14 2016-11-18 2016-11-22 2016-11-18 Injury
6109884 2016-03-25 2016-11-12 2016-11-17 2016-11-17 Injury
6102339 2011-06-15 2016-10-26 2016-11-15 2016-11-15 Malfunction
6080398 2016-10-13 2016-10-13 2016-11-04 2016-11-04 Injury
6064399 2016-10-05 2016-10-06 2016-10-31 2016-10-28 Malfunction
6057616 2016-09-28 2016-09-29 2016-10-26 2016-10-26 Injury

6043554 2016-08-01 2016-09-23 2016-10-20 2016-10-20 Malfunction
6041429 2016-05-10 2016-10-20 2016-11-10 2016-10-19 Malfunction
6016010 2016-09-07 2016-10-07 2016-10-10 2016-10-10 Malfunction
5939632 2016-08-18 2016-08-18 2016-09-09 2016-09-09 Injury
5940507 2016-08-12 2016-08-15 2016-08-15 2016-09-09 Injury
5936138 2016-08-12 2016-09-08 2016-09-08 Injury

5937712 2016-08-11 2016-08-11 2016-08-11 2016-09-08 Injury
5933146 2016-08-13 2016-08-17 2016-09-07 2016-09-07 Injury
5934404 2016-08-15 2016-08-15 2016-09-09 2016-09-07 Injury
5890364 2015-07-01 2016-07-28 2016-08-19 2016-08-19 Malfunction
5866958 2015-08-28 2016-07-19 2016-07-19 2016-08-10 Injury
5853500 2016-07-13 2016-07-13 2016-07-13 2016-08-08 Injury
5815435 2016-06-29 2016-08-05 2016-08-19 2016-07-22 Malfunction
5813031 2016-06-06 2016-06-27 2016-07-21 2016-07-21 Malfunction
5802705 2009-06-02 2016-08-12 2016-08-22 2016-07-19 Malfunction
5799463 2015-06-30 2016-06-23 2016-07-15 2016-07-15 Malfunction

5769339 2015-01-01 2016-06-06 2016-07-07 2016-07-05 Malfunction
5729322 2016-05-19 2016-05-19 2016-06-16 2016-06-16 Injury
5727864 2015-08-17 2016-05-23 2016-06-15 2016-06-15 Injury
5704345 2016-05-12 2016-05-12 2016-06-07 2016-06-07 Malfunction
5600035 2016-03-25 2016-04-22 2016-04-22 Injury
5593177 2016-03-22 2016-03-22 2016-04-20 Injury
5585534 2016-03-24 2016-04-21 2016-03-24 2016-04-18 Injury

5554688 2013-08-20 2016-03-15 2016-04-07 2016-04-07 Injury
5550567 2016-02-12 2016-03-15 2016-04-06 2016-04-06 Injury
5543025 2016-03-07 2016-04-01 2016-04-01 Injury
5516471 2016-02-24 2016-03-22 2016-03-22 Injury
5517892 2016-02-26 2016-02-26 2016-03-22 Injury

5511607 2016-01-08 2016-02-19 2016-02-19 2016-03-18 Injury
5486697 2016-02-10 2016-04-01 2016-04-05 2016-03-08 Malfunction
5484795 2016-03-16 2016-04-01 2016-03-07 Malfunction
5477181 2016-02-05 2016-02-05 2016-02-05 2016-03-03 Injury
5460066 2015-04-23 2016-01-29 2016-01-29 2016-02-25 Injury
5460069 2015-04-23 2016-01-29 2016-01-29 2016-02-25 Injury

5454594 2016-01-21 2016-04-06 2016-04-06 2016-02-23 Injury
5416029 2015-04-19 2016-01-13 2016-01-13 2016-02-08 Malfunction
5414736 2016-01-15 2016-03-21 2016-03-21 2016-02-06 Injury
5411702 2016-01-13 2016-01-13 2016-02-04 Injury
5387094 2015-11-07 2016-02-02 2015-12-28 2016-01-22 Injury
5341472 2016-02-10 2015-12-11 2016-01-04 Injury

5342433 2016-01-04 2015-12-06 2016-01-04 Injury
5324205 2015-12-03 2015-12-03 2015-12-23 Injury
5324635 2016-01-28 2015-12-02 2015-12-23 Malfunction
5324700 2016-01-28 2015-12-02 2015-12-23 Malfunction
5325003 2015-11-25 2016-03-09 2016-03-09 2015-12-23 Injury

5318346 2013-10-23 2015-12-24 2015-11-30 2015-12-22 Injury
5318374 2013-10-23 2015-12-24 2015-11-30 2015-12-22 Injury
5320926 2015-12-04 2016-03-29 2015-12-04 2015-12-22 Injury
5297739 2010-12-27 2016-01-11 2015-11-23 2015-12-15 Injury
5299204 2015-12-30 2015-12-30 2015-12-15 Malfunction
5295024 2015-11-19 2015-11-19 2015-12-14 Injury
5288861 2015-11-16 2015-11-16 2015-12-11 Injury

5251684 2015-12-22 2015-12-22 2015-11-25 Malfunction
5246764 2015-10-22 2015-10-28 2015-10-28 2015-11-24 Injury
5223711 2015-06-08 2015-10-15 2015-10-15 2015-11-15 Malfunction
5218934 2015-10-16 2016-03-15 2016-04-07 2015-11-11 Injury
5167337 2015-09-05 2015-09-29 2015-09-29 2015-10-21 Injury

5144211 2015-07-15 2015-10-29 2015-09-25 2015-10-12 Malfunction
5129029 2015-09-08 2015-09-08 2015-09-08 2015-10-05 Injury
5104523 2015-09-01 2015-09-01 2015-09-25 Malfunction

5053120 2015-08-07 2015-08-07 2015-09-03 Injury
5055167 2015-09-16 2015-08-07 2015-09-03 Injury
5039736 2015-04-04 2015-09-08 2015-07-31 2015-08-28 Injury
5039959 2015-08-04 2015-08-04 2015-08-28 Malfunction
5028257 2015-08-01 2015-08-28 2015-08-02 2015-08-25 Injury
5029085 2015-08-03 2015-08-03 2015-08-25 Injury
5020922 2015-06-22 2015-08-28 2015-07-29 2015-08-21 Injury
4997308 2015-07-09 2015-08-13 2015-08-13 2015-08-12 Injury
4977039 2015-08-26 2015-07-14 2015-08-06 Malfunction

4939852 2015-06-29 2015-08-24 2015-06-30 2015-07-24 Injury
4900003 2015-06-16 2015-07-09 2015-06-16 2015-07-08 Injury
4863262 2015-06-04 2015-06-04 2015-06-23 Malfunction
4853520 2015-08-21 2015-05-27 2015-06-18 Injury
4841950 2015-04-10 2015-06-30 2015-06-30 2015-06-12 Injury
4813224 2015-05-12 2015-05-12 2015-06-02 Malfunction
4808642 2015-05-08 2015-05-08 2015-05-08 2015-06-01 Injury

4809559 2015-03-01 2015-08-15 2015-05-12 2015-06-01 Malfunction
4809789 2015-05-01 2014-06-02 2015-05-06 2015-06-01 Injury
4785560 2015-04-30 2015-05-20 2015-05-01 2015-05-20 Injury
4767786 2015-04-20 2015-04-20 2015-05-13 Injury

4756443 2015-03-21 2015-06-09 2015-04-14 2015-05-07 Injury
4753897 2015-04-07 2015-06-04 2015-06-04 2015-05-06 Injury
4729051 2015-04-01 2015-04-04 2015-04-04 2015-04-25 Injury
4721840 2015-04-01 2015-04-01 2015-04-01 2015-04-23 Injury
4704583 2015-03-21 2015-03-25 2015-03-25 2015-04-17 Injury
4699339 2015-04-22 2015-03-25 2015-04-16 Injury

4699424 2014-07-28 2015-04-02 2015-04-13
4673949 2015-03-19 2015-03-19 2015-04-09 Injury
4674276 2014-03-19 2016-04-07 2016-04-08 2015-04-09 Injury
4674567 2015-03-12 2015-05-01 2015-05-01 2015-04-09 Injury

4652511 2015-03-04 2015-03-06 2015-03-06 2015-04-02 Injury
4650481 2015-03-03 2015-05-20 2015-03-03 2015-04-01 Injury
4644204 2015-03-11 2015-03-11 2015-03-31 Injury
4645832 2015-03-10 2015-03-10 2015-03-31 Malfunction
4609170 2005-01-01 2005-01-01 2015-03-17 Injury
4582132 2016-01-08 2015-02-17 2015-03-09 Injury
4578310 2015-02-13 2015-02-13 2015-02-13 2015-03-06 Injury
4484781 2015-01-07 2015-01-08 2015-01-08 2015-02-04 Injury

4485141 2015-01-14 2015-01-14 2015-02-04 Malfunction
4463103 2015-05-20 2015-01-06 2015-01-29 Malfunction
4460155 2014-01-07 2015-01-06 2015-01-06 2015-01-28 Injury
4398704 2014-12-15 2014-12-15 2014-12-15 2015-01-08 Injury

4352868 2014-11-16 2015-01-19 2014-11-30 2014-12-22 Injury
4347718 2014-11-26 2014-11-26 2014-12-19 Injury
4318197 2014-11-06 2014-12-10 2014-11-20 2014-12-10 Injury
4318603 2014-11-12 2014-11-12 2014-12-10 Injury

4309380 2014-12-23 2014-11-13 2014-12-09 Injury
4295499 2015-04-23 2014-11-11 2014-12-03 Injury
4281883 2013-12-09 2014-11-05 2014-11-05 2014-11-26 Malfunction

4282256 2014-07-25 2014-10-29 2014-10-29 2014-11-26 Injury
4265122 2010-01-01 2014-10-23 2014-10-23 2014-11-17 Injury
4250577 2014-10-21 2014-10-22 2014-10-22 2014-11-14 Malfunction
4226804 2014-10-11 2014-12-08 2014-10-14 2014-11-05 Malfunction
4228459 2014-10-16 2015-01-14 2014-10-17 2014-11-05 Injury

4228673 2014-10-10 2015-09-21 2015-09-21 2014-11-05 Malfunction
4203178 2014-10-07 2014-10-07 2014-10-27 Injury
4195871 2013-11-20 2014-09-29 2014-09-29 2014-10-23 Injury
4197201 2015-01-09 2014-10-03 2014-10-23 Injury

4178956 2014-09-26 2014-09-26 2014-10-16 Injury
4164948 2014-09-10 2014-09-12 2014-09-12 2014-10-10 Injury
4156310 2014-10-17 2014-09-19 2014-10-09 Injury
4152865 2014-10-28 2014-09-15 2014-10-08 Injury
4144398 2014-11-11 2014-10-01 2014-10-06 Malfunction

4116022 2014-08-25 2014-08-25 2014-09-24 Injury
4090643 2014-08-21 2014-08-21 2014-08-21 2014-09-15 Injury
4080386 2014-08-13 2014-08-13 2014-09-11 Injury
4077374 2014-08-13 2014-08-13 2014-08-13 2014-09-10 Injury
4054869 2014-08-07 2014-10-22 2014-08-08 2014-09-03 Injury

4042258 2014-07-31 2014-10-07 2014-08-02 2014-08-27 Injury
4042270 2014-07-31 2014-10-07 2014-08-02 2014-08-27 Injury
4030530 2014-09-18 2014-07-29 2014-08-22 Injury
4008598 2014-07-19 2014-07-19 2014-08-14 Malfunction
4003871 2014-08-29 2014-07-17 2014-08-12 Malfunction
4055963 2014-07-10 2014-08-07 2014-08-08 Injury

3973433 2014-07-07 2014-07-07 2014-08-01 Injury
3973589 2015-09-28 2014-07-08 2014-08-01 Injury
3961187 2015-03-30 2014-07-08 2014-07-28 Injury
3931693 2013-06-26 2014-08-15 2014-08-15 2014-07-14 Injury
3929648 2014-07-07 2014-07-08 Injury

3912003 2014-06-12 2014-06-12 2014-07-03 Injury
3949620 2014-06-06 2014-06-12 2014-06-12 2014-07-01 Injury

3899910 2014-11-11 2014-06-05 2014-06-27 Injury
3900788 2015-10-16 2014-06-04 2014-06-27 Injury
3888757 2014-05-29 2014-05-29 2014-06-23 Injury

3882258 2014-05-23 2015-03-30 2014-05-24 2014-06-18 Injury
3868827 2014-05-19 2014-09-02 2014-05-19 2014-06-12 Injury
3890955 2014-05-15 2014-05-16 2014-05-16 2014-06-04 Injury
3866794 2014-02-24 2014-06-02 2014-06-03 Injury

3841477 2014-07-15 2014-05-12 2014-05-30 Malfunction
3835627 2014-08-12 2014-05-21 2014-05-28 Malfunction
3833300 2014-04-17 2014-04-30 2014-04-30 2014-05-27 Malfunction

3819437 2014-04-23 2014-09-26 2014-04-23 2014-05-19 Injury
3802704 2014-04-17 2014-04-17 2014-05-09 Injury
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3643019 2014-04-10 2014-02-03 2014-02-24 Malfunction
3632174 2014-01-25 2014-01-27 2014-01-27 2014-02-18 Malfunction
3683387 2014-01-28 2014-01-28 2014-01-28 2014-02-18 Injury
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3584832 2013-12-13 2013-12-27 2013-12-27 2014-01-21 Malfunction
3557225 2013-04-05 2014-01-07 2014-01-07 2014-01-07 Injury

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3536383 2013-12-03 2014-03-12 2014-03-12 2013-12-24 Injury
3534064 2013-12-05 2013-12-05 2013-12-23 Malfunction
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3649410 2013-11-12 2013-11-12 2013-11-12 2013-12-06 Injury
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3464874 2013-10-23 2013-10-23 2013-11-12 Injury

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3458564 2013-07-01 2014-09-29 2013-04-23 2013-11-08 Malfunction
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3413177 2002-09-24 2013-12-06 2013-09-27 2013-10-16 Injury
3422552 2013-08-28 2013-09-21 2013-09-21 2013-10-11 Injury
3422560 2013-08-28 2013-09-21 2013-09-21 2013-10-11 Injury

3422597 2013-08-28 2013-09-21 2013-09-21 2013-10-11 Injury
3397681 2013-09-18 2013-10-14 2013-09-18 2013-10-09 Injury
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3367585 2013-08-30 2013-08-30 2013-09-25 Malfunction
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3358732 2013-12-16 2013-08-26 2013-09-19 Injury
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3366430 2013-08-21 2013-08-22 2013-08-22 2013-09-17 Injury

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3330417 2013-09-30 2013-08-12 2013-09-06 Injury

3327283 2013-08-09 2013-10-09 2013-08-09 2013-09-05 Injury
3348936 2008-08-28 2013-08-14 2013-08-14 2013-09-05 Injury
3319751 2013-08-23 2013-08-23 2013-08-30 Injury
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3311063 2014-03-20 2013-08-02 2013-08-27 Malfunction
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3326302 2013-07-25 2013-07-25 2013-07-25 2013-08-22 Injury

3295180 2013-06-21 2013-07-24 2013-07-24 2013-08-19 Injury
3291114 2013-05-31 2013-07-15 2013-07-15 2013-08-08 Injury
3291115 2013-05-31 2013-07-15 2013-07-15 2013-08-08 Injury
3267357 2013-07-11 2013-08-19 2013-07-12 2013-08-06 Injury
3291309 2013-07-13 2013-07-15 2013-07-15 2013-08-06 Injury
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3212903 2013-08-21 2013-06-14 2013-07-09 Injury
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3164632 2013-07-25 2013-06-04 2013-06-12 Injury
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3149417 2011-02-01 2013-05-07 2013-05-07 2013-05-31 Injury
3122873 2013-04-30 2013-06-26 2013-05-02 2013-05-21 Injury
3120517 2013-04-28 2013-05-01 2013-05-01 2013-05-20 Malfunction
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3059898 2013-03-22 2013-12-16 2013-03-23 2013-04-16 Injury
3052779 2013-05-31 2013-03-21 2013-04-11 Malfunction
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3059451 2012-07-01 2013-03-19 2013-03-19 2013-04-11 Injury

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3044716 2013-03-13 2013-04-17 2013-03-13 2013-04-09 Injury
3040933 2013-03-04 2013-04-12 2013-03-13 2013-04-08 Injury
3036172 2013-03-19 2013-03-19 2013-04-04 Malfunction
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3024769 2013-03-03 2013-03-04 2013-03-04 2013-03-25 Injury
3018318 2013-02-19 2013-02-20 2013-02-20 2013-03-22 Injury
3017122 2013-02-20 2013-03-04 2013-03-04 2013-03-19 Injury

3002220 2014-04-16 2013-02-26 2013-03-13 Injury
2995216 2013-02-06 2013-07-23 2013-02-21 2013-03-08 Injury
3001507 2013-02-11 2013-02-11 2013-02-11 2013-03-05 Injury

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2966205 2013-09-03 2013-09-03 2013-02-18 Malfunction
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2946083 2013-01-23 2014-04-09 2013-05-23 2013-02-06 Injury
2928575 2013-01-02 2013-01-02 2013-01-02 2013-01-22 Malfunction
2928576 2013-01-02 2013-01-02 2013-01-02 2013-01-22 Malfunction
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852399 2007-04-13 2007-04-16 2007-04-16 2007-05-03 Injury
820851 2007-01-19 2007-01-19 2007-01-19 2007-02-16 Injury
817167 2007-01-10 2007-01-13 2007-02-08 2007-02-08 Injury

773875 2006-09-26 2006-09-26 2006-10-25 Injury
771397 2006-08-28 2006-08-28 2006-08-28 2006-10-17 Injury
769661 2006-08-17 2006-08-17 2006-08-17 2006-10-11 Injury
767326 2006-03-25 2006-03-31 2006-03-31 2006-10-03 Injury
761575 2006-08-14 2006-08-14 2006-08-14 2006-09-13 Injury
708950 2006-04-07 2006-04-07 2006-05-05 Other
708972 2006-04-07 2006-04-07 2006-05-05 Other

678143 2006-02-15 2006-02-15 2006-02-21 Other
645979 2005-08-30 2005-10-11 2005-10-11 2005-11-10 Other
639037 2005-09-13 2005-09-15 2005-09-15 2005-09-30 Injury
565621 2005-01-03 2005-01-03 2005-01-03 2005-01-11 Injury
533601 2004-04-14 2004-04-14 2004-07-09 Injury
482441 2003-08-26 2003-08-28 2003-08-28 2003-09-08 Injury
472070 2003-06-20 2003-06-20 2003-07-14 Injury
451151 1998-06-29 2003-03-26 2003-03-26 Injury
421655 2002-09-11 2002-09-26 2002-09-26 2002-10-11 Injury
402170 2002-05-08 2002-05-30 2002-05-30 2002-06-25 Injury
398532 2002-05-13 2002-05-13 2002-06-07 Injury
366333 2001-07-09 2001-07-13 2001-07-13 2001-12-13 Injury
307659 2000-10-26 2000-10-30 2000-10-30 2000-12-04 Injury
305317 1998-05-23 2000-10-30 2000-10-30 2000-11-16 Other
219030 1998-11-22 1999-04-06 1999-04-06 1999-04-13 Injury

212699 1998-10-21 1998-10-22 1998-10-22 1999-03-01 Injury
198057 1998-10-21 1998-10-22 1998-10-22 1998-11-17 Injury
189187 1998-03-31 1998-07-24 1998-07-24 1998-09-24 Injury
128963 1997-09-09 1997-10-29 Injury
84673 1996-02-01 1997-03-12 1997-03-12 1997-04-15 Injury

Report Source Reporter Occupation Company Name Product Code
Manufacturer report Medtronic LGW
Manufacturer report OTHER Medtronic LGW

Manufacturer report ATTORNEY Medtronic LGW
Manufacturer report OTHER Nevro LGW
Voluntary report PATIENT Medtronic LGW
Manufacturer report Boston Scientific LGW
Manufacturer report PHYSICIAN Boston Scientific LGW

Voluntary report PATIENT Medtronic GZB


Manufacturer report PHYSICIAN Medtronic LGW

Manufacturer report NOT APPLICABLE Abbot LGW
Manufacturer report PHYSICIAN Abbot LGW
Manufacturer report Nevro LGW


Manufacturer report Med Rel LGW
Manufacturer report PHYSICIAN Nuvectra Corporation LGW
Manufacturer report BIOMEDICAL ENGINEER Stimwave Technologies Inc. GZB

Manufacturer report Abbot LGW
Manufacturer report RISK MANAGER Medtronic LGW
Voluntary report PATIENT FAMILY MEMBER ORBoston Scientific LGW

Manufacturer report BIOMEDICAL ENGINEER Stimwave Technologies Inc. GZB
Voluntary report RISK MANAGER Medtronic LGW

Manufacturer report Med Rel LGW

Manufacturer report OTHER Abbot GZB
Manufacturer report PHYSICIAN Abbot GZB

Manufacturer report OTHER Med Rel LGW
Manufacturer report PATIENT FAMILY MEMBER ORMedtronic LGW

Voluntary report PATIENT FAMILY MEMBER ORUnk LGW

Manufacturer report HEALTH PROFESSIONAL Medtronic LGW
Manufacturer report PATIENT Medtronic LGW

Manufacturer report OTHER Abbot LGW

Voluntary report PATIENT Boston Scientific GZB



Voluntary report PATIENT Boston Scientific LGW




Manufacturer report PATIENT Boston Scientific LGW






Manufacturer report PHYSICIAN Med Rel LGW
Manufacturer report PATIENT FAMILY MEMBER ORBoston Scientific LGW












Voluntary report OTHER Boston Scientific LGW
Manufacturer report PHYSICIAN ASSISTANT Medtronic LGW

Manufacturer report OTHER Medtronic GZB




Manufacturer report NOT APPLICABLE Abbot GZB




Voluntary report PHYSICIAN Medtronic LGW

Voluntary report PATIENT Boston Scientific LGW



Manufacturer report OTHER Boston Scientific LGW
Voluntary report PATIENT Nevro LGW



















Voluntary report PATIENT Ans GZB





Manufacturer report MEDICAL ASSISTANT Medtronic LGW


Manufacturer report HEALTH PROFESSIONAL Boston Scientific LGW


Manufacturer report PHYSICIAN ASSISTANT Boston Scientific LGW





Manufacturer report PHYSICIAN ASSISTANT Boston Scientific LGW
Voluntary report OTHER LGW
Manufacturer report OTHER HEALTH CARE PROFEMedtronic LGW


Manufacturer report NOT APPLICABLE Medtronic LGW

Voluntary report RISK MANAGER Ans - Rep Terri Guches LGW


Manufacturer report NOT APPLICABLE Boston Scientific LGW

Manufacturer report NOT APPLICABLE St. Jude LGW









Voluntary report PATIENT Medtronic LGW

Manufacturer report OTHER St. Jude LGW
Manufacturer report NURSE Medtronic LGW
Manufacturer report NURSE Medtronic LGW
Manufacturer report UNKNOWN Boston Scientific LGW

Manufacturer report PHYSICIAN Medtronic GZB

Manufacturer report OTHER St. Jude LGW
Manufacturer report OTHER Advanced Bionics LGW
Manufacturer report OTHER Advanced Bionics GZB


Manufacturer report OTHER St. Jude GZB
Manufacturer report PHYSICIAN Advanced Bionics LGW

Manufacturer report ATTORNEY Med Rel LGW

Manufacturer report PHYSICIAN Med Rel GZB
Manufacturer report OTHER Neuro GZB
Manufacturer report OTHER Neuro GZB
Manufacturer report OTHER Mnpro GZB
Voluntary report OTHER HEALTH CARE PROFESt. Jude GZB
Manufacturer report ATTORNEY Medtronic GZB

Manufacturer report NURSE Medtronic GZB
Manufacturer report NURSE Medtronic GZB
Manufacturer report PATIENT FAMILY MEMBER ORMedtronic GZB
Voluntary report ATTORNEY Medtronic GZB
Manufacturer report ATTORNEY Medtronic GZB

Device Name Brand Name Generic Name
Stimulator, Spinal-Cord, TotallyINTELLIS STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallySURESCAN STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallySPINAL CORD STIMULATION TRSTIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallySENZA NEVRO SENZA
Stimulator, Spinal-Cord, TotallyPAIN RELIEVER STIMULATOR PAIN RELIEVER STIMULATOR
Stimulator, Spinal-Cord, TotallyNI SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyPRECISION SPECTRA SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallySURESCAN STIMULATOR, SPINAL-CORD, IM
Stimulator, Spinal-Cord, TotallyRESTORE ULTRA STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, ImplantNEUROSTIMULATOR/SPINAL C NEUROSTIMULATOR/SPINAL C

Stimulator, Spinal-Cord, TotallyRESTORE STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyRESTORE SENSOR STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyITREL II STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyNEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyLAMITRODE 88C LEAD KIT, 60 SCS LEAD
Stimulator, Spinal-Cord, TotallyRESTORE RECHARGEABLE NEU STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyPRECISION SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyPENTA 3MM LEAD, 60 CM SCS LEAD
Stimulator, Spinal-Cord, TotallyCOVEREDGE 32 STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Stimulator, Spinal-Cord, TotallyIMPLANTABLE NEUROSTIMULASTIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyRESTORE ADVANCED STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyALGOVITA SPINAL CORD STIMUSTIMULATOR, SPINAL CORD, TO
Stimulator, Spinal-Cord, ImplantFREEDOM SPINAL CORD STIMUL

SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyPRECISION SPECTRA STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyPRECISION SPINAL CORD STIM STIMULATOR, SPINAL CORD

Stimulator, Spinal-Cord, ImplantFREEDOM SPINAL CORD STIMUL
SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyINTELLIS SPINAL STIMULATOR STIMULATOR, SPINALCORD, TOT

Stimulator, Spinal-Cord, TotallySYNERGY STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, ImplantPENTA 3MM LEAD, 60 CM SCS LEAD
Stimulator, Spinal-Cord, TotallyINFINION 16 STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyCOVEREDGE 32 SURGICAL LEADSPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallyNEVRO HF10 SPINAL CORD ST STIMULATOR FOR PAIN RELIEF
Stimulator, Spinal-Cord, TotallyPRECISION MONTAGE MRI SPINAL CORD STIMULATOR


Stimulator, Spinal-Cord, TotallyPROCLAIM 7 ELITE SCS IPG
Stimulator, Spinal-Cord, TotallyEXTERNAL NEUROSTIMULATORSTIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyITREL 3 STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyRESTORE PRIME STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, ImplantBOSTON SCIENTIFIC PRECISIO BOSTON SCIENTIFIC PRECISION SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyUNKNOWN IMPLANTABLE NEUSTIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, ImplantOCTRODE TRIAL LEAD KIT, 60 SCS LEAD

Stimulator, Spinal-Cord, ImplantLAMITRODE TRIPOLE 16 LEAD, SCS LEAD
Stimulator, Spinal-Cord, ImplantOCTRODE LEAD KIT, 90CM LEN SCS LEAD
Stimulator, Spinal-Cord, TotallyPROCLAIM� ELITE 7 IPG SCS IPG
Stimulator, Spinal-Cord, TotallySYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyPRECISION MONTAGE SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyPRECISION SPINAL CORD STIM STIMULATOR ELECTRICAL

Stimulator, Spinal-Cord, TotallyPRIMEADVANCED STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallyPRECISION MONTAGE MRI SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallyPRECISION SPECTRA� SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallyNI SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, ImplantOCTRODE LEAD KIT, 60CM LEN SCS OCTRODE
Stimulator, Spinal-Cord, TotallyUNKNOWN STIMULATOR, SPINAL-CORD, TO






Stimulator, Spinal-Cord, TotallySPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TO


Stimulator, Spinal-Cord, TotallySPECIFY STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyRESTORE LEAD STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyRESTORE LEAD STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, ImplantPROT�G� MRI IPG SCS IPG

Stimulator, Spinal-Cord, TotallySPINAL CORD STIMULATION LESTIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallySPINAL CORD STIMULATION LESTIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyEXTN 37081-60 OCTAD 1X8 STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallySPECIFY STIMULATOR, SPINAL-CORD, TO



Stimulator, Spinal-Cord, TotallyPRECISION� SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyEXTERNAL NEUROSTIMULATIOSTIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyITREL II STIMULATOR, SPINAL-CORD, TO



Stimulator, Spinal-Cord, ImplantLAMITRODE 44 LEAD KIT, 60C SCS LEAD

Stimulator, Spinal-Cord, TotallyINFINION LEAD FOR A TRIAL S INFINION LEAD FOR A TRIAL S

Stimulator, Spinal-Cord, ImplantSURESCAN STIMULATOR, SPINAL-CORD, IM
Stimulator, Spinal-Cord, ImplantGENESIS PULSE GENERATOR, 8 SCS IPG
Stimulator, Spinal-Cord, TotallyUNKNOWN EXTERNAL NEUROSSTIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, ImplantLAMITRODE TRIPOLE 16 LEAD, SCS

Stimulator, Spinal-Cord, TotallyPRIME ADVANCED MRI STIMULATOR, SPINAL-CORD, TO


Stimulator, Spinal-Cord, ImplantLAMITRODE TRIPOLE 16C SCS LEAD

Stimulator, Spinal-Cord, TotallySPECTRA SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallyRESTORE SENSOR MRI STIMULATOR, SPINAL-CORD, IM


Stimulator, Spinal-Cord, Totally Implanted For Pain Relief NEUROSTIMULATOR

Stimulator, Spinal-Cord, TotallyRESTORE ULTRA MRI STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyPRECISION PLUS SPINALCORD STIMULATOR

Stimulator, Spinal-Cord, ImplantLAMITRODE TRIPOLE 16 SCS LEAD


Stimulator, Spinal-Cord, ImplantEONC SCS IPG
Stimulator, Spinal-Cord, TotallySPINAL CORD STIMULATOR SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallySTIMULATOR 37021 RX1 EXTE STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallySPECTRA� SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, ImplantLAMITRODE TRIPOLE 16 SCS LEAD
Stimulator, Spinal-Cord, ImplantPENTA SCS LEAD

Stimulator, Spinal-Cord, ImplantOCTRODE SCS LEAD

Stimulator, Spinal-Cord, TotallyEXTERNAL NEUROSTIMULATO STIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyUNKNOWN STIMULATOR STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyUNKNOWN EXTERNAL STIMULSTIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallySYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, ImplantLAMITRODE TRIPOLE 16
Stimulator, Spinal-Cord, ImplantLAMITRODE 44C

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, ImplantPENTA
Stimulator, Spinal-Cord, ImplantEON MINI

Stimulator, Spinal-Cord, TotallySINGLE EXTENSION SCS IPG
Stimulator, Spinal-Cord, TotallyEON MINI SCS IPG

Stimulator, Spinal-Cord, TotallySINGLE EXTENSION SCS IPG
Stimulator, Spinal-Cord, TotallyEXTERNAL NEUROSTIMULATORSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELI


Stimulator, Spinal-Cord, TotallyEONC SCS IPG

Stimulator, Spinal-Cord, TotallyOCTRODE SCS LEAD
Stimulator, Spinal-Cord, TotallyPENTA SCS LEAD

Stimulator, Spinal-Cord, TotallyGENESIS SCS IPG
Stimulator, Spinal-Cord, TotallyQUATTRODE SCS LEAD

Stimulator, Spinal-Cord, TotallyDUAL EXTENSION SCS EXTENSION



Stimulator, Spinal-Cord, ImplantANS SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyUNKNOWN NEUROSTIMULATOSTIMULATOR, SPINAL-CORD, TO
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16 SCS LEAD
Stimulator, Spinal-Cord, TotallyCHARGING SYSTEM SCS CHARGING SYSTEM

Stimulator, Spinal-Cord, TotallyCARGING SYSTEM SCS CHARGING SYSTEM
Stimulator, Spinal-Cord, TotallyLAMITRODE S8 SCS LEAD



Stimulator, Spinal-Cord, TotallyQUATTRODE SCS LEAD

Stimulator, Spinal-Cord, TotallyLAMITRODE 44C SCS LEAD
Stimulator, Spinal-Cord, TotallyUKNOWN IMPLANTABLE NEURSTIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, ImplantLAMITRODE 88C SCS LEAD

Stimulator, Spinal-Cord, TotallyNEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyLAMITRODE 88 SCS LEAD
Stimulator, Spinal-Cord, TotallyEXTERNAL NEUROSTIMULATO STIMULATOR, SPINAL-CORD, TO


Stimulator, Spinal-Cord, TotallyXTREL STIMULATOR, SPINAL-CORD, TO

Stimulator, Spinal-Cord, TotallyOCTRODE TRIAL LEAD KIT, 60 SCS LEAD
Stimulator, Spinal-Cord, TotallyOCTRODE TRIAL LEAD KIT, 60 SCS LEAD



Stimulator, Spinal-Cord, TotallyPENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyMEDTRONIC NEUROSTIMULAT NEUROSTIMULATOR MEDTRON
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16 LEAD, SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyEON MINI IPG, 16-CHANNEL R TOTALLY IMPLANTABLE PULSE

Stimulator, Spinal-Cord, TotallyOCTRODE LEAD KIT, 60CM LEN SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyEON MINI IPG, 16-CHANNEL R TOTALLY IMPLANTABLE PULSE

Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16C SURGSPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyRESTORE ULTRA
Stimulator, Spinal-Cord, TotallySYNERGY

Stimulator, Spinal-Cord, TotallyANS LEAD PENTA SPINAL CORD STI
Stimulator, Spinal-Cord, TotallyUNKNOWN SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyEXTERNAL NEUROSTIMULATOR
Stimulator, Spinal-Cord, TotallyLAMITRODE 4 LEAD, 90CM LE SPINAL CORD STIMULATION LE

Stimulator, Spinal-Cord, TotallyPENTA SURGICAL LEAD SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16C LEADSPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyGENESIS PULSE GENERATOR, 8 TOTALLY IMPLANTABLE PULSE


Stimulator, Spinal-Cord, TotallyLAMITRODE TRIOPOLE 16 SPINAL CORD, IMPLANTABLE, (P

Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16 SPINAL CORD, IMPLANTABLE, (P
Stimulator, Spinal-Cord, TotallyEON MINI-IPG IMPLANTABLE PULSE GENERAT
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16 LEAD SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyOCTRODE PERCUTANEOUS LEASPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyEONC CONVENTIONAL IPG IMPLANTABLE PULSE GENERAT
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16C SURGSPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyOCTRODE LEAD PERCUTANEOUS LEAD

Stimulator, Spinal-Cord, TotallyLAMITRODE 88 LEAD SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16C LEADSPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyLAMITRODE 44 LEAD SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyEON IMPLANTABLE PULSE GENTOTALLY IMPLANTABLE PULSE
Stimulator, Spinal-Cord, TotallyRESTORE RECHARGEABLE NEUROSTIMULATOR
Stimulator, Spinal-Cord, TotallyIPG

Stimulator, Spinal-Cord, TotallyEON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERAT
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16 LEAD SPIN CORD STIMULATION LEAD
Stimulator, Spinal-Cord, TotallyTRIPOLE 16 LAMITRODE LEAD SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyNARROW LAMITRODE TRIPOLESPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyLAMITRODE 88 SURGICAL LEADSPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyOCTRODE TRIAL LEAD KIT, 60C SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyEON IMPLANTABLE PULSE GENTOTALLY IMPLANTABLE PULSE
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE 16 LEAD, SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallySPECIFY 5X6X5 LEAD



Stimulator, Spinal-Cord, TotallyRESTORE RECHARGABLE NEUROSTIMULATOR
Stimulator, Spinal-Cord, TotallyUNK SPINAL CORD STIMULATOR

Stimulator, Spinal-Cord, TotallyUNK SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, TotallyMEDTRONIC NEUROSTIMULATOR
Stimulator, Spinal-Cord, TotallyRESTORE PRIME
Stimulator, Spinal-Cord, TotallyRESTORE RECHARGEABLE NEUROSTIMULATOR

Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE LEAD SPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyLAMITRODE NARROW TRIPOLESPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyITREL 3
Stimulator, Spinal-Cord, TotallyITREL 3

Stimulator, Spinal-Cord, TotallyUNKNOWN SPINAL STIMULATOR
Stimulator, Spinal-Cord, TotallyLEAD NEURO
Stimulator, Spinal-Cord, TotallyLAMITRODE TRIPOLE LEAD 16CSPINAL CORD STIMULATION LE
Stimulator, Spinal-Cord, TotallyEON 16-CHANNEL IPG IMPLANTABLE PULSE GENERAT
Stimulator, Spinal-Cord, TotallyRESTORE PRIME ADVANCED
Stimulator, Spinal-Cord, ImplantSPECIFY
Stimulator, Spinal-Cord, TotallyLEAD NEURO
Stimulator, Spinal-Cord, TotallyUNKNOWN UNK
Stimulator, Spinal-Cord, TotallySPECIFY 5X6X5 LEAD
Stimulator, Spinal-Cord, TotallyCOMPACT LOW IMPEDANCE LEAD

Stimulator, Spinal-Cord, TotallyTRIPOLE 16C LAMITRODE LEADSPINAL CORD STIMULATION SU
Stimulator, Spinal-Cord, TotallyIPG NEURO
Stimulator, Spinal-Cord, TotallyLAMITRODE DUAL 88 LEAD SPINAL CORD STIMULATION SU
Stimulator, Spinal-Cord, TotallyPRECISION SPINAL CORD STIMULATOR LE
Stimulator, Spinal-Cord, ImplantPRECISION SPINAL CORD STIMULATOR LE

Stimulator, Spinal-Cord, TotallyHINGED 2 X 4 LEAD
Stimulator, Spinal-Cord, ImplantSPECIFY

Stimulator, Spinal-Cord, ImplantLAMITRODE DUAL 88 ELECTROSPINAL CORD STIMULATION SU
Stimulator, Spinal-Cord, ImplantSPECIFY GZB
Stimulator, Spinal-Cord, TotallyRESTORE RESTORE ADVANCED LGW

Stimulator, Spinal-Cord, TotallyRESTORE RECHARGABLE NEUR LGW
Stimulator, Spinal-Cord, Implant1X8 TEST STIMULATION LEAD GZB
Stimulator, Spinal-Cord, TotallyHINGED 2 X 4 LEAD LGW
Stimulator, Spinal-Cord, ImplantPISCES - QUAD LEAD
Stimulator, Spinal-Cord, TotallySYNERGY IPG
Stimulator, Spinal-Cord, TotallySYNERGY IPG

Stimulator, Spinal-Cord, ImplantSPECIFY LEAD
Stimulator, Spinal-Cord, ImplantITREL 3 INSR
Stimulator, Spinal-Cord, ImplantPISCES - QUAD LEAD
Stimulator, Spinal-Cord, ImplantITREK LEAD
Stimulator, Spinal-Cord, ImplantPISCES QUAD LEAD
Stimulator, Spinal-Cord, ImplantNEUROMED -ADVANCED NEURO

LEADS NEUROMED DUAL OCTRO
Stimulator, Spinal-Cord, ImplantITREL LEAD
Stimulator, Spinal-Cord, ImplantPISCES QUAD LEAD
Stimulator, Spinal-Cord, ImplantITREL LEAD
Stimulator, Spinal-Cord, ImplantRESUME LEAD
Stimulator, Spinal-Cord, ImplantDBS NEUROSTIMULATION LEAD
Stimulator, Spinal-Cord, ImplantITREL IMPLANTABLE PULSE GENERAT
Stimulator, Spinal-Cord, ImplantRESUME TL LEAK KIT FOR SPINAL CORD ST

Stimulator, Spinal-Cord, ImplantRESUME SURGICAL EPIDURAL LEAD
Stimulator, Spinal-Cord, ImplantRESUME SURGICAL EPIDURAL LEAD
Stimulator, Spinal-Cord, ImplantSPECIFY NEUROSTIMULATION LEAD
Stimulator, Spinal-Cord, ImplantRESUME RESUME II SPINAL CORD STIMULATOR
Stimulator, Spinal-Cord, ImplantRESUME NEUROSTIMULATION LEAD

Model Number Catalog Number Device Class Device Events URL
97715 97715 3 htp://subscribe.deviceevents

NEU_ENS_STIMULATOR NEU_ENS_STIMULATOR 3 htp://subscribe.deviceevents
NIPG1500 NIPG1500 3 htp://subscribe.deviceevents
3 htp://subscribe.deviceevents
NI NA 3 htp://subscribe.deviceevents
SC-8352-70 NA 3 htp://subscribe.deviceevents
37714 2 htp://subscribe.deviceevents

NEU_INS_STIMULATOR NEU_INS_STIMULATOR 3 htp://subscribe.deviceevents

SC-8116-70 3 htp://subscribe.deviceevents
LEAD1058-90B LEAD1058-90B 3 htp://subscribe.deviceevents
SC-8336-50 SC-8336-50 3 htp://subscribe.deviceevents
LEAD3005-70B 3 htp://subscribe.deviceevents
FR8A-TRL-A0;FR8A-TRL-B0 2 htp://subscribe.deviceevents
SC-1132 SC-1132 3 htp://subscribe.deviceevents
SC1132 3 htp://subscribe.deviceevents
FR8A-TRL-A0,FR8A-TRL-B0 2 htp://subscribe.deviceevents
MRI RS2 97715 3 htp://subscribe.deviceevents

SC-2316-50E SC-2316-50E 3 htp://subscribe.deviceevents

SC-2352-50E NA 3 htp://subscribe.deviceevents


C PRECISION SPINAL CORD STIMULATOR 2 htp://subscribe.deviceevents

7427V 7427V 3 htp://subscribe.deviceevents

SC-1132 NA 3 htp://subscribe.deviceevents


SC-1032B NA 3 htp://subscribe.deviceevents





39565-65 39565-65 3 htp://subscribe.deviceevents
NEU_UNKNOWN_LEAD NEU_UNKNOWN_LEAD 3 htp://subscribe.deviceevents
NEU_UNKNOWN_LEAD NEU_UNKNOWN_LEAD 3 htp://subscribe.deviceevents



SC-8336-70 N/A 3 htp://subscribe.deviceevents




SC2316-50E 3 htp://subscribe.deviceevents












7427V 7427V 3 htp://subscribe.deviceevents


AL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF 3 htp://subscribe.deviceevents





SC-2218-50E N/A 3 htp://subscribe.deviceevents








37712 NA 3 htp://subscribe.deviceevents
MANF #3228 LAWSON 357654 3 htp://subscribe.deviceevents
UNKNOWN NA 3 htp://subscribe.deviceevents
IPGNEURO NA 3 htp://subscribe.deviceevents
UNK NA 3 htp://subscribe.deviceevents
7427V NA 3 htp://subscribe.deviceevents
SC-2218-50T NA 3 htp://subscribe.deviceevents
UNK UNK 3 htp://subscribe.deviceevents
LEADN NA 3 htp://subscribe.deviceevents
LEADN NA 3 htp://subscribe.deviceevents
SC-2138-50T NA 3 htp://subscribe.deviceevents
3487A NA 2 htp://subscribe.deviceevents
7427V NA 3 htp://subscribe.deviceevents
LEAD NA 2 htp://subscribe.deviceevents
3487A 3487A-33 2 htp://subscribe.deviceevents
* 2198 * 2 htp://subscribe.deviceevents
3587A 3586 * 2 htp://subscribe.deviceevents
Keyword(s) spinal paralysis O criticalEvent
count 681 19
FDA MAUDE URL spinal paralysis O criticalEvent Total Term Count
htps://www.acces 1 1 2
CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 977C165, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE LEAD. I
21-FEB-2022, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. INFORM
POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE PATIENT HAD A MEDICAL HISTORY OF POST-TRAUMAT
MANAGE BETTER AT HOME. THEY STATED THAT THEY MONITOR IT AT HOME BY TAKING MAGNESIUM CITRATE AND EATING RIG
STILL ON AND THEY WERE NOT SURE WHAT WAS GOING ON. THEY STATED THAT THEIR FEET WERE NUMB AND THEY �FELT LI
NUMB FROM THE WAIST DOWN. THE PATIENT STATED THAT THEY WERE CURRENTLY ADMITTED TO THE HOSPITAL AFTER THEI
LEG, BUT THIS A.M. IT SEEMED WORSE. THE PATIENT STATED THAT THEIR HEALTHCARE PROVIDER (HCP) HAD TAKEN X-RAYS, A
THE SURGERY. THE PATIENT STATED THAT SATURDAY NIGHT THEY HAD TROUBLE WITH TWITCHING. THEY STATED THEY RAISED
BELONG TO THEM AND LIKE THEY WERE DETACHED AND PUT TOGETHER WITH WIRES AND ALL THE WAY UP THEIR LEG FELT N
WELL. THEY STATED THAT THEIR FEET WERE NUMB AND THEY COULD NOT WALK BECAUSE THEY WERE NUMB FROM THE WAI
WONDERFULLY. THE PATIENT STATED THAT TWO NIGHTS AGO, THEIR RIGHT LEG WAS JERKING LIKE THEY HAD A TENS UNIT ON
THERAPY, HOWEVER THEY COULD NOT FEEL THEIR FOOT AND REALLY WANTED THEIR UNIT CHECKED BY THE MANUFACTURER
UP LIKE A BEACH BALL AS WELL, PROBABLY FROM THE SALINE THEY GAVE THEM. THE EVENT BEGAN ON (B)(6) 2018. AN EMAIL
GOT THEIR PERMANENT IMPLANT LAST WEDNESDAY, (B)(6) AND THEY WALKED IN ALL EXCITED AND CAME OUT AND THEY CO
ANYTHING. THE PATIENT STATED THAT THEIR DOCTOR TOLD THE PATIENT �S MOTHER THERE WAS SCAR TISSUE AND THE UNIT
TO TURN TO THE LEFT GOING WHERE THE HCP DID NOT WANT IT TO GO AND THEY FINALLY GOT IT IN TO STAY. THE PATIENT ST
TENS UNIT ON THEIR FEET. THEY STATED THAT THEIR FEET WERE LIKE FROZEN, NOT NUMB, BUT THEY COULDN �T STAND ON
NOT HAVE ANYTHING TO TURN IT DOWN WITH, THEY DID NOT GIVE THEM ANYTHING (DID NOT HAVE A CONTROLLER). THE PA
THE HOSPITAL, THEY CHECKED IN BECAUSE THEIR LEGS WERE NOT WORKING RIGHT. THE PATIENT STATED THAT KEPT ASKING T
HOSPITAL DISMISS THEM. NOW THEY WERE STUCK IN A WHEELCHAIR. THE PATIENT STATED THAT THEY TRIED TO USE THEIR LE
HAS STAYED THAT WAY AND GETS WORSE. THEY WERE NOT DOING ANYTHING, AND THEY WANTED TO DO PHYSICAL THERAPY
WAS A CT WITH CONTRAST. THE PATIENT DID NOT KNOW THE RESULTS. THE PATIENT ALSO REPORTED HAT SINCE WEDNESDAY
WERE �JUST GIVING THEM STUFF THAT GIVES DIARRHEA �. THE PATIENT STATED NOW THEY WOULDN �T GO FOR A FEW DA
WAS HARD TO SIT TOO AND IT FELT LIKE SOMEONE HAD A TIGHT BELT AROUND THEM PULLING ON IT. THEY WANTED TO KNOW
THE RIGHT LEG HAD BEEN DOING THAT JERKING MOTION SINCE SATURDAY. THE PATIENT STATED THAT THEY WERE IN A LOT OF
WERE NOT LISTENING. THE PATIENT STATED THAT THEY HAD SO MUCH PAIN RIGHT NOW AND THEIR LEG WAS TOTALLY NUMB
IN THE ROOM AND STATED THEY WERE A NEUROSURGEON. THEY WERE TRANSFERRED TO THE NATIONAL ANSWERING SERVIC
DIARRHEA, STOMACH ISSUES, PAIN AND PAIN AT THE IMPLANT SITE OCCURRED SINCE IMPLANT ((B)(6) 2018). THE ISSUE OF TH
DAY AGAIN ASKING A MANUFACTURER REPRESENTATIVE (REP) TO COME OUT TO TEST THE DEVICE. THEY STATED THEY WERE G
THEY THOUGHT IT WAS ON BECAUSE THEIR FEET WERE TINGLING ALL THE WAY UP THEIR HIP. THEY COULD HARDLY WALK. TH
LIFE SITTING IN BED AND THEY HATED SITTING IN BED. IT WAS INDICATED THAT THE PATIENT SUSPECTED A PROBLEM WITH TH
WOKE UP FROM SURGERY AND 5 DAYS LATER THEY WERE STILL IN THE HOSPITAL AND THEIR FEET WERE TINGLING NUMB AND
HURTS NOW MORE THAN BEFORE THEY GOT THEIR IMPLANT AND THEIR HEALTH GOT WORSE THERE WOULD BE PROBLEMS F
INFORMATION WAS RECEIVED FROM A FAMILY MEMBER/FRIEND CONCERNING CONSUMER WITH IMPLANTABLE NEUROSTIMU
ABLE TO LAST SUCCESSFULLY CHARGE THE DEVICE �TUESDAY MORNING. � THEY WERE NOT ABLE TO COMMUNICATE WITH A
DEPLETING MAY BE DUE TO HIGHER PROGRAMMING, BUT THEY WEREN'T SURE. CALLER STATED THE STIMULATOR DIED OVER
FROM THE THERAPY. THE PATIENT WILL HAVE A LITTLE MORE PAIN WITH EXTRA ACTIVITY, BUT IT IS NOT RELATED TO AN ISSUE
(6) 2010 WHEN HE HAD THE INITIAL PROBLEM. CALLER STATED HIS LEGS JUST GIVE OUT. CALLER STATED HE WAS IN A WHEELC
THE PATIENT�S LEGS WILL JUST GIVE OUT AND HE "GOES DOWN". CALLER STATED HE DOESN'T TYPICALLY FALL ON HIS STIMU
THERAPY CONTROL FOR THE CONSTANT PAIN THE STIMULATOR WAS IMPLANTED FOR. THE PATIENT WAS REDIRECTED TO THE
REPORTED/ANTICIPATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A LEGAL REPRESENTATIVE OF A PATIENT REPORTING THAT SPINAL CORD STIMULATION T
HAD A HISTORY OF CHRONIC BACK PAIN. PATIENT HAD UNDERGONE SEVERAL SURGICAL PROCEDURES TO THE LUMBAR REGIO
HAD A HISTORY OF ATRIAL FIBRILLATION, A CONDITION WHICH CAUSES AN IRREGULAR HEARTBEAT (ARRHYTHMIA) THAT CAN
PATIENT HAD BEEN PRESCRIBED AND WAS TAKING COUMADIN, A BLOOD THINNING MEDICINE USED TO TREAT BLOOD CLOTS A
THORACIC SPINE. PRIOR AND IN PREPARATION FOR THE TRIAL PROCEDURE, UNDER THE DIRECTION OF HEALTHCARE PROFESS
TREAT AND PREVENT DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM FOLLOWING CERTAIN TYPES OF SURGERY. AN AP
OF HEALTHCARE PROVIDER, PATIENT RESUMED TAKING PRESCRIBED ANTICOAGULANT/BLOOD THINNER MEDICATION. ON THA
EVENING. LATER IN THAT EVENING, PATIENT'S SPOUSE CALLED MANUFACTURER REPRESENTATIVE (REP) TO REPORT THE SEVER
REP TOLD PATIENT THEY HAD COMMUNICATED WITH THE PHYSICIAN AND THE PHYSICIAN RECOMMENDED PATIENT TO TAKE A
PATIENT'S BACK PAIN CONTINUING TO WORSEN, PATIENT CALLED THE REP AND DISCUSSED WHETHER THEY SHOULD GO TO EM
A LOCAL EMERGENCY ROOM WOULD LIKELY REMOVE THE TRIAL DEVICE AND THEREBY EFFECTIVELY TERMINATE THE STIMULA
2015. THE PATIENT MET WITH ANOTHER MANUFACTURER REPRESENTATIVE AS SCHEDULED THE DAY PRIOR. THE REP INSPECTE
CONTINUED TO INCREASE. ON THE EVENING, THE PAIN HAD BECOME UNBEARABLE AND PATIENT WENT TO EMERGENCY ROO
CAUSE OF PATIENT'S LOWER EXTREMITY NEUROLOGIC SYMPTOMS, GIVEN THE FACT THAT THE LEADS FOR THE TRIAL WERE PL
APPROXIMATELY 1:05 AM, PATIENT REPORTED A CHANGE IN SENSATION IN THEIR BACK AND LEGS, INCLUDING A LOSS OF FEEL
TO T8 AND THAT, THEREFORE, A THORACIC MRI WAS REQUIRED. A THORACIC SPINE MRI WAS NOT CONDUCTED UNTIL APPRO
LARGE THORACIC EPIDURAL HEMATOMA WITH CORD COMPRESSION. THE THORACIC MRI IDENTIFIED A MASS AT T4-8 SEVERE
FACILITY DID NOT HAVE A NEUROSURGEON AVAILABLE TO PERFORM A MULTILEVEL LAMINECTOMY NECESSARY TO EVACUATE
CORD DECOMPRESSION. UPON ADMISSION, PHYSICIANS ORDERED MRI OF PATIENT'S SPINE AND DIAGNOSED SEVERE IMPING
WERE PERFORMED TO REMOVE EPIDURAL BLOOD CLOTS FROM THE SPINE. BY THAT TIME, PATIENT HAD SUFFERED SEVERE AN
EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD
SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED TO NEVRO THAT A PATIENT HAD PASSED AWAY IN (B)(6) 2017. ABOUT A MONTH PRIOR TO THE PASSING, TH
INCIDENT WAS RELATED TO THE PATIENT'S DEATH. NEVRO HAD ATTEMPTED TO OBTAIN A MEDICAL ASSESSMENT REGARDING
MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND.
ON (B)(6) 2016, I HAD A MEDTRONIC PAIN RELIEVER STIMULATOR INTERNALLY INSTALLED IN MY BODY BY DR. (B)(6) AT THE ME
PLACED OVER THE GENERATOR PORTION OF THE DEVICE FROM THERE THE INTERNAL WIRING CONSENT OF TWO WIRES THAT
THE SHOULDER BLADES AND A FOOT FROM THE BRAIN. THE OBJECTIVE OF THE MEDTRONIC PAIN RELIEVER STIMULATOR IS TO
BUMPS UP AND DOWN UNTIL THEY TARGET THE PAIN AREA. THERE IS A LEFT AND RIGHT CONTROLS SO WHEN IN THE FULL CH
AMOUNT OF SIGNALS. NOW THE PT CONTROLLER WHEN PLACED OVER AND THROUGH THE SKIN WILL HAVE A LEFT AND RIGH
WORKED GREAT. I PUSHED MY PAIN PILLS AWAY AND RESUMED MY ACTIVITIES WITH LITTLE MEDICATION. THIS MEDTRONIC P
TO A TRAILER. I HAD MY CONTROLLER IN MY TOP POCKET WITH THE WIRES HANGING OUT TO MAKE ADJUSTMENTS IF NEEDE
ELECTROCUTED. MORE INTENSE THAN THE HOUSEHOLD ELECTRIC, LIKE BEING WRAPPED WITH WIRE AND PLUGGED INTO ELE
FEET AWAY LOOKING AT ME. THE CONTROLLER WIRE HAPPENED TO BE HANGING OUT OF MY POCKET SO HER ACTIONS WITH
MY RIGHT HIP. BECAUSE THE CONDITIONS WERE JUST RIGHT, I LIVED TO TELL THE FACTS OF THE REALITY THAT IT WAS AN ELEC
TRACE OF THE TRUE SOURCE OF DEATH. EVEN IF MY WIFE WOULD HAVE HAD HER HEAD TURNED THE OTHER WAY, I WOULD H
MACHINE WAS STUDIED THERE WOULD BE A FEW MYSTERIOUS DEATHS, MASSIVE HEART ATTACK. THE CHANCE IS SO LITTLE W
ACTIONS. THAT'S WHY I'M THE ONLY SURVIVOR AND I TESTIFY THAT PAST OR FUTURE DEATHS WILL OCCUR IF THIS IS NOT IMM
BROKEN TO PIECES AND IN A WHEELCHAIR IN CONSTANT PAIN AND I'M SUPPOSED TO BE CONSIDERED LUCKY. BUT THIS HAS T
. A REPORT WAS RECEIVED VIA SOCIAL MEDIA THAT CLAIMS TWO PATIENTS HAD PROBLEMS WITH THEIR SCS SYSTEMS. THE CO
THE COMPLAINANT FURTHER REPORTS THAT THE LEADS CANNOT BE REMOVED BECAUSE OF THE POSSIBILITY OF PARALYSIS O
A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PARALYSIS IN HIS LEGS. TH
PHYSICIAN ASSESSED THAT THE EPIDURAL HEMATOMA AND PARALYSIS WERE DUE TO THE PROCEDURE. THE MRI REVEALED A
PROCEDURE. DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. X
POTENTIALLY RELATE TO THE REPORTED EVENT. SC-1132 � S/N (B)(4): IMPEDANCE MEASUREMENTS WERE WITHIN THE EXPE
WERE VERIFIED TO BE CORRECT ON ALL THE ELECTRODES. DC LEAKAGE AND CURRENT LEAKAGE TESTS VERIFIED NO LOSS OF E
PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY
INVOLVED IN THE EVENT: MODEL: SC-1132 SERIAL/LOT: (B)(4) DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENERA
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) FROM A COMPANY REPRESENTATIVE (REP) STATING THAT THEY SAW THE
THAT THE SPINAL CORD STIMULATION (SCS) DEVICE CAUSED THEM TO BREAK THEIR HIP AND BECOME WHEELCHAIR BOUND.
THEIR PAIN. WITHOUT STIMULATION, THE PATIENT WAS A 9-10 ON THE PAIN SCALE, AND WITH THE SCS DEVICE THEIR PAIN W
STIMULATION VERY MILD AND FOLLOW UP WITH THEIR PHYSICIAN IF FURTHER ASSISTANCE WAS NEEDED WITH THEIR PAIN CO
MAGNETIC RESONANCE IMAGING (MRI) CONDUCTED TO DETERMINE IF THERE WAS ANY DAMAGE. THEY ALLEGED THAT THE D
ELECTROCUTED AND WHEN THE DEVICE CAUSED DAMAGE WAS THE DAY THAT THEY HAD FALLEN, NOTED TO BE (B)(6) 2016. (B
ADJUSTMENT WAS NEEDED. A COMPANY REPRESENTATIVE (REP) REPORTED ON 2016-03-04 STATING THAT THE PATIENT FELT S
ELECTROCUTING THEM AND SHOCKING THEM "LIKE THEIR FINGERS WERE STUCK IN THE WALL". THEIR SPOUSE HAD TO RUSH
THEN THEY WOULD FALL DOWN. THE PATIENT STATED THAT IF THEIR SPOUSE HAD NOT BEEN THERE, THEY COULD HAVE DIED
THEY HAD MAXED OUT ALL OF THEIR PAIN MEDICATION. IT WAS STATED THAT THEY HAD A BROKEN BONE AND THEY DEFECAT
NOT BEEN IMPLANTED. HOWEVER, IT WAS ALSO FOUND THAT THE PATIENT HAD STIMULATION TURNED ON BECAUSE THEY CO
THE PATIENT HAD TOLD THE REP THAT IT HAD HAPPENED WHEN THEY WERE STANDING UP WAVING TO HIS SPOUSE AS THEY W
PATIENT YET TO CHECK THE DEVICE. ACCORDING TO THE PATIENT, THE ADAPTIVE STIMULATION WAS OFF. THE PATIENT WAS G
PATIENT CLARIFIED THAT THE REASON THEY FELL AND BROKE THEIR HIP AND KNEE WAS DUE TO ONE OF THE SHOCKING EPISO
OF THE FALL WHICH RESULTED IN BROKEN HIP AND KNEE. THE STIMULATION HAD WORKED GREAT FOR A FEW WEEKS AND TH
BROKEN KNEE AND HIP. THE PATIENT WAS DIRECTED TO DISCUSS ALL CONCERNS WITH THEIR HCP AND REP. ADDITIONAL INFO
PATIENT THAT EVERYTHING CHECKED OUT FINE AND SUGGESTED THAT THEY TURN STIMULATION DOWN AND OFF AS NEEDED
RESONANCE IMAGING (MRI). THE PATIENT WAS DIRECTED TO THEIR HCP TO DISCUSS THE EVENT ISSUES. THE INDICATION FOR
INFORMATION IS RECEIVED. .
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-6
THE CONSUMER AND MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THAT THE PATIENT HAD POOR COUPLING WHEN R
COUPLING BARS. THE DEVICE WAS TOO DEEP AT THE TIME OF THE REPORT. THE PATIENT WAS GETTING GREAT THERAPY. THER
TO THEIR SKIN DUE TO THE WEIGHT GAIN. LATER, IT WAS REPORTED THE BATTERY WAS REPLACED WITH A NON-RECHARGEAB
RECHARGING, BUT RECENTLY HE PASSED AWAY. IT WAS NOTED THE PATIENT ALSO HAD A (B)(6) POUND WEIGHT LOSS AND DI
RECHARGEABLE ONE. WITH THE PATIENT BEING IN A WHEEL CHAIR, SHE HAD TOO MUCH DIFFICULTY TRYING TO POSITION TH
REPLACEMENT WHICH PROVIDED GREAT STIMULATION COVERAGE TO HER LOW BACK AND DOWN HER LEGS BILATERALLY. AT T
ON (B)(6) 3015, AT (B)(6), DR (B)(6) IMPLANTED A SPINAL CORD STIMULATOR IN MY BACK AND THE BATTERY WAS PLACED ABO
WAS THE BATTERY. HOWEVER, IT CONTINUED TO BE PAINFUL. THEN 2 MONTHS AGO, I HAD EXCRUCIATING PAIN AND I WENT T
SURGERY TO MOVE FROM BACK TO LEFT SIDE ON (B)(6) 2015. I HAD THAT SURGERY. I WAS THERE ALL DAY FOR A MINOR SURG
RELEASED SAME DAY. ON (B)(6) 2015, I HAD A 101 FEVER AND COULD HARDLY MOVE. ON (B)(6) 2015, I WAS MOVING BETTER
MY MOTHER CALLED 911 AND I WENT TO (B)(6) MEDICAL CENTER. BY THE TIME I GOT LOOKED AT BY THE ER DOCTOR, NOT EV
ANTIBIOTIC DID BLOODWORK AND CALLED DOCTOR (B)(6) IN (B)(6) (HE DOESN'T GO TO (B)(6)). (B)(6) PARTNER SAID TO DISCH
BUT BRUISED, AND HE IS NOT SAYING I DON'T HAVE AN INFECTION ELSEWHERE BUT HE DISCOUNTED A SITE INFECTION. HE W
ER. TWO DOCTORS SAID IT WAS INFECTED AND THEN THEY TOLD ME I HAD SEPSIS AND HAD ICU DOCTORS WHO SAID IT WAS
(6) CALLED THE ICU DOCTOR WHO IS IN CHARGE OF THE ENTIRE ICU AND TOLD DR. (B)(6) THAT HE INSPECTED THE SITE AND IT
TO THE SURGEON AS HE WAS WRONG AND I COULD HAVE DIED. I WAS IN ICU FROM (B)(6) 2015 AND UNTIL THE EVENING OF
TO DECIDE WHETHER THEY, A NEW SURGEON WILL DRAIN SOME FLUID TO TEST IT. THE OTHER ISSUE WAS THE TRIAL STIMULA
PERMANENT ONE IS NOTHING LIKE IT. VERY HARD TO CHARGE, AS HARD TO REACH SITE TO TURN IF ON. HARD TO CHARGE IF Y
DECISION ON (B)(6) ON CHARGEABLE VS NONCHARGEABLE BATTERY. WE WERE NOT TOLD ABOUT THE TWO AND NOW I HAVE
SHIFTS" AND HAVE TO GET REPOSITIONED AND INFECTION RATE HIGH AS WELL. THEN I WAS TOLD IT COULD BE REMOVED, AN
PARALYSIS." WOW. CURRENTLY ON ANTIBIOTICS, VANCOMYCIN, FLAGYL AND CEFEPIME.
(B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT RECOVERED, AND THE SYSTEMS AND ISS
CORD STIMULATOR (SCS) REMOVED FOR THE PAST 3 MONTHS AS IT NEVER ALLEVIATED HER PAIN SIGNIFICANTLY ENOUGH. IT
REPORTED 75% PAIN RELIEF IN HER LOW BACK AND BILATERAL LEGS DURING THE TIME OF THE TRIAL. SHE WAS ALSO TAKING
THE PATIENT UNDERWENT A PERMANENT SCS PLACEMENT AND SHE TOLERATED THE PROCEDURE WELL WITH NO COMPLICAT
AT 8/10 RADIATING INTO BILATERAL LOWER EXTREMITIES. THERE WAS AT LEAST 40% OF PAIN RELIEF AFTER PERMANENT SCS P
STIMULATOR WAS NOT WORKING FOR HER AND SHE HAD RELIEF FOR ONLY 3 DAYS AFTER THE IMPLANT. AFTER THE THREE DA
IMAGING WAS DONE IN THE OFFICE TO EVALUATE LEAD PLACEMENT. THERE WAS NO ADVERSE CHANGE IN THE POSITION OR
ERYTHEMA WAS OBSERVED. THE PATIENT MET WITH THE DOCTOR TO DISCUSS HAVING THE REMOVAL OF THE SCS BATTERY. T
THE INSERTION AND THE STIMULATOR HAD NOT WORKED WELL SINCE THEN. THE DOCTOR HAD TAKEN C-ARM FLUOROSCOPIC
MANUFACTURING REPRESENTATIVE (REP), NO SATISFACTORY RELIEF COULD BE ACCOMPLISHED. THE RISK OF PROCEDURE INC
PATIENT WAS ANXIOUS TO PROCEED. IT WAS LATER REPORTED THAT A SURGERY WAS GOING TO BE SCHEDULED TO REMOVE T
THAT A MANUFACTURING REPRESENTATIVE WAS WORKING WITH THE PATIENT TO DO ADAPTIVESTIM (AS) REPROGRAMMING
NEUROSTIMULATOR (INS) WAS RECOGNIZING THE APPROPRIATE POSITION FOR UPRIGHT AND LYING DOWN. THE CAUSE OF TH
NECK CAUSED STIMULATION. THE MANUFACTURING REPRESENTATIVE FIXED HER TRANSITION SETTINGS. THEY ADJUSTED POS
FELT APPROPRIATE STIMULATION DURING THOSE POSITIONS. THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. WHEN T
WELL HEALED, AND IT DID NOT APPEAR TO HAVE ANY SIGNS OF INFECTION. THE PAIN WAS ABOUT 1 � ABOVE THE INCISION S
ABOUT 7-10 DAYS POST IMPLANT. THE STIMULATION WAS TO COVER HER LEGS. SHE WAS ADVISED TO SEE HER SURGEON FOR
IMPLANTING PHYSICIAN FOR EVALUATION. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS REC
PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED A LETTER FROM THE MANUFACTURER A MONTH PRI
HADN'T WORKED IN YEARS AND THE MEDICATION THE PATIENT WAS ON WASN'T DOING ANYTHING. IT WAS METHADONE, BU
4 AM. THE PATIENT WENT TO THE HEALTHCARE PROVIDER (HCP) THE NIGHT PRIOR. THEY WOULDN'T DO ANYTHING ABOUT TH
THEY COULD DIE, LIFE WAS NOT WORTH IT. THE PATIENT REALLY WAS, THEY WERE TIRED OF HURTING. THE WORK INJURY WA
WAS WRONG AND THEN SENT THE PATIENT BACK TO WORK THAT DAY. THEY TOOK THE PATIENT TO A QUACK THAT WAS SUPPO
THEY MISSED THE VEIN 3 TIMES SO THEY DIDN'T GET THE EXACT AMOUNT OF DYE NEEDED FOR THEIR VEIN SO THE RESULTS W
SURGERY. THEN THE PATIENT HAD REFLEX SYMPATHETIC DYSTROPHY (RSD). IT WAS ASKED OF THE PATIENT IF IT WAS THEIR LE
SIDE. THE PATIENT COULDN'T WALK SO THEY WERE TRYING TO GET A MOTORIZED WHEELCHAIR. THEY TOLD THE PATIENT THA
BACKWARDS TO BE ABLE TO SCOOT THEMSELVES S AROUND BECAUSE THEY DIDN'T HAVE A WHEELCHAIR. HALF OF THE PEOPL
COULDN'T SLEEP AT NIGHT, EVEN BREATHING ON THEIR SKIN HURT. THE PATIENT NOTED AGAIN THAT THEY WANTED TO DIE. (
WORKING WITH THEIR HEALTHCARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. THE PATIENT WAS ASKING FOR A
TYPE: EXTENSION. PRODUCT ID: 377745, LOT# V010660, IMPLANTED: (B)(6), 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37752
PROGRAMMER, PATIENT. PRODUCT ID: 377745, LOT# V008879, IMPLANTED: (B)(6), 2006, PRODUCT TYPE: LEAD. PRODUCT ID:
STIMULATOR ON. A COMMUNICATION PROBLEM WAS REPORTED. THE PATIENT STATED ON (B)(6) 2014, THE PATIENT �S BATTE
OFF LIKE THIS FOR YEARS (5-6 YEARS). SHE STATED IT ALWAYS TURNED OFF SO SHE HAD BEEN COPING WITH THE PAIN. THE PA
YEARS. THE PATIENT HAD A PAIN PHYSICIAN, BUT HAD NOT BROUGHT THE ISSUE UP WITH HIM AS HE DIDN �T KNOW ANYTHI
CHARGING (AFTER APPEARING TO DO A JUMP START BUT THE DATE OF THIS WAS UNCLEAR),AND STATED IT WAS SHOWING IT
ON RESET (POR) WAS DISPLAYED. THE PATIENT WAS REDIRECTED TO A PHYSICIAN, AS THE POR WOULD NEED CLEARING BY A P
THE DEVICE, INTERVENTIONS, AND OUTCOME. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS AT THE HOSPITAL WITH PARAPLEGIA SECONDARY TO
TRANSFERRED TO A REHABILITATION FACILITY, WHERE HE WAS DOING WELL UNTIL HE DEVELOPED ABDOMINAL PAIN, NAUSEA
OBSTRUCTION DUE TO CONSTIPATION. HE WAS GIVEN SOME ENEMAS ALONG WITH DULCOLAX. LIVER FUNCTION TESTS (LFT)
THE PATIENT WAS NOT STABLE. HE WAS HYPOTENSIVE ON PRESSORS. SUPPORTIVE THERAPY WAS CONTINUED, HOWEVER, AT
FROZEN PLASMA TO REVERSE HIS INR OF 2.38, AND WAS TAKEN EMERGENTLY TO SURGERY, WHERE HE WAS FOUND TO HAVE
AND MESENTERIC ISCHEMIA. A CONFERENCE WAS HELD WITH THE FAMILY, AND IT WAS DECIDED TO GIVE THE PATIENT COMF
ISCHEMIC GUT, HYPOTENSION, ACUTE RESPIRATORY FAILURE REQUIRING INTUBATION, SEVERE METABOLIC ACIDOSIS, SHOCK L
SMALL BOWEL OBSTRUCTION; CONSTIPATION; PARAPLEGIA SECONDARY TO THORACIC STENOSIS SECONDARY TO EPIDURAL HE
CHRONIC PAIN SYNDROME; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; NEUROGENIC BOWEL AND BLADDER. (B)(4). PROD
SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)
(B)(6) 2014. THERE WAS NO ALLEGED PRODUCT ISSUE. THE PATIENT HAD DEVELOPED AN EPIDURAL HEMATOMA 48HOURS AF
SENT TO THE HOSPITAL LAB. THE PATIENT HAD A HISTORY OF BLEEDING, HAD MECHANICAL HEART VALVE AND HAD RECEIVED
HAD OCCURRED 48 HOURS POST-OPERATIVE. THE PATIENT HAD STAYED IN THE HOSPITAL FOR 2 WEEKS AND HAD REGAINED T
BEEN DOING FINE UNTIL THE BOWEL INFARCT. THE PATIENT HAD EXPERIENCED AN INFARCT OF THE BOWEL AND HAD BEEN BR
PATIENT WAS A HIGH RISK AND TWO SURGEONS HAD DENIED THE PATIENT FOR GENERATOR REPLACEMENT DUE TO RISK FACT
BOWEL SURGERY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT CAUSE OF THE DEATH WAS POSSIBLE ISCHEMIC BOW
INFORMATION NOTED ATRIAL FIBRILLATION, HEART VALVE REPLACEMENT ON ANTICOAGULATION. . ADDITIONAL INFORMATIO
PRICK HOLE IN THE PATIENT'S DURA. THE PATIENT WAS WALKING AND DOING WELL WHEN DISCHARGED FROM PROCEDURE. T
PATIENT WAS ON ORAL ANTICOAGULANTS. IT WAS STATED THAT THE PATIENT HAD THE BOWEL INFARCT SURGERY AT ANOTHE
PATIENT HAD AN AUTOPSY.
PRODUCT ID 3998, LOT# VA05BEJ, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97740, SERIAL# (B)(4); PRODUC
(B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION
LONGER THAN THIRTY-SIX HOURS. IT WAS REPORTED THAT THREE TO FOUR MONTHS PRIOR TO CALL, THE PATIENT STARTED C
REPORTED, IT TOOK THREE HOURS TO CHARGE. IT WAS NOTED, THE DEVICE WAS NOT HELPING WITH PAIN AND THE PATIENT I
BATTERY STARTED TO DIE AND THE PATIENT WAS IN PAIN. IT WAS REPORTED, THE PATIENT �S STIMULATOR WAS BEING REPLA
PATIENT HAD STIMULATION AND NO COMPLAINT ABOUT THERAPY. IT WAS REPORTED, THE PATIENT REQUIRED THE HELP OF T
THE PATIENT DID NOT CHARGE AND THE DEVICE WAS DEAD.
ADDITIONAL REVIEW INDICATED THAT THIS REPORT INVOLVED THE DEVICE THAT HAD BEEN IN THE PATIENT'S STOMACH AND
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) IN THE PATIENT'S STOMA
TO NOTICE EROSION. IT WAS REPORTED THAT IT ERODED ALL THE WAY THROUGH HER SKIN AT ONE TIME AND CAUSED HER TO
BLOOD TRANSFUSIONS. IT WAS REPORTED THAT SURGERY WAS DONE AND THE DEVICE WAS REMOVED, AND THE PATIENT HA
PUSHED OUT OF HER SKIN. IT WAS NOTED THAT THE PATIENT'S BODY RECOVERED AND FULLY HEALED FROM THE EXPLANTED
AND REGAIN USE OF HER ARMS AND HANDS. HOWEVER, IT GOT TO A POINT WHERE HER �BODY WAS REJECTING THE DEVICE
TIMES. BY �BLEW OUT� THE PATIENT CLARIFIED THE DEVICES �CAME OUT OF HER � AND SHE WAS �HEMORRHAGING TO
THERE WAS A RELIEF FROM THE PAIN, SHE WANTED THE DEVICE PUT BACK INTO HER, EXCEPT THIS TIME IN HER BACK. SLOWLY
�HURT HER�, THE ONE IN HER NECK WAS BOTHERING HER AND THE ONE IN HER LOWER BACK WAS REMOVED AND �SOM
PAIN FROM THE SCAR TISSUE ON HER RIGHT SIDE WHERE THE BATTERIES WERE. THE PATIENT WENT ON TO HAVE A PAIN PUM
PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4) THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED
NEU_INS_STIMULATOR, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).
ADDITIONAL REVIEW INDICATED THAT THIS REPORT INVOLVED THE DEVICE �IN HER NECK � AND NOT THE DEVICE THAT HAD
PATIENT�S STOMACH. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS P
ALL DEVICE COMPONENTS WERE REMOVED ABOUT FIVE YEARS AGO. IT WAS REPORTED THAT OVERALL, THE DEVICES HELPED
THE EXPLANTED DEVICES. (B)(4). IT WAS REPORTED THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) PLACED AN
REJECTING THE DEVICE.� IT WAS STATED THE DOCTOR IMPLANTED THE DEVICE IN HER STOMACH AND IT �BLEW OUT � SO
�HEMORRHAGING TO DEATH.� THE PATIENT TOLD HER DOCTOR SHE DID NOT WANT THE DEVICE IN HER STOMACH. THE PA
TIME IN HER BACK. SLOWLY SHE WAS THEN ABLE TO WALK WITHOUT A WHEELCHAIR, CRUTCH, OR BRACE. REPORTEDLY THE P
REMOVED AND �SOME OF THE WIRES WERE BOTHERING HER, � SO EVERYTHING CAME OUT. THE PATIENT DID NOT HAVE AN
TO HAVE A PAIN PUMP IMPLANTED AND HAD A FULL RECOVERY. REFERENCE REG REPORT # 3007566237-2013-02730.
IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO WEAKNESS IN HER LEGS. AN EPIDURAL HEMATOMA
PARALYSIS FROM THE EPIDURAL HEMATOMA. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY
PHYSICIAN REGARDING MEDICAL HISTORY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GOING TO HAVE THE DEVICE REMOVED. SHE WOND
NEUROSTIMULATOR (INS) HAD BEEN DEAD SINCE 2011 AND HAD NOT WORKED AND WHEN SHE TRIED TO CHARGE THE INS IT
CHARGE." THE PATIENT WANTED TO KNOW HOW MANY LEADS AND ELECTRODES SHE HAD IN THE BACK. SHE ALSO WONDERE
COULD HAVE AN MRI OF THE SHOULDER. SHE ASKED IF IT WOULD BE DIFFICULT TO REMOVE THE WIRES DUE TO SCAR TISSUES
ISSUES FROM A PRIOR SURGERY. THE PATIENT HAD GAINED WEIGHT AND ASKED IF THERE WAS A ROUGH IDEA ON HOW A SUR
REPLACED. UPDATED TO: IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS "COMPLETELY DEAD." LATER, THE PATIENT SAW
"AT LEAST A YEAR." THE PATIENT HAD CHARGED THE INS BATTERY "LAST YEAR AND IT JUST DIED." THE PATIENT HAD A LOSS OF
SEPTEMBER 11TH. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEIN
MANUFACTURER REPORT # 3004209178-2011-05364
PATIENT WEIGHT NOT AVAILABLE. DEVICE REMAINS IN PATIENT. THIS IS THE FINAL REPORT. A REPORT WAS RECEIVED THAT TH
PULMONARY EMBOLISM AND WAS PRESCRIBED COUMADIN FOR ANTICOAGULATION. AS A RESULT, A SPINAL HEMATOMA OC
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS IN THEIR LEGS THE SAME DAY THAT THEIR LEAD WAS IMPLANTE
EXTENSION. ISSUE WAS RESOLVED. THE INVESTIGATION RESULTS WILL BE PROVIDED ON THE FINAL REPORT.
IT WAS REPORTED TO NEVRO THAT THE PATIENT WAS HOSPITALIZED DUE TO PARALYSIS FROM A STROKE. THE STROKE WAS NO
NO ADDITIONAL INFORMATION WAS AVAILABLE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES WERE FO
IT WAS REPORTED TO NEVRO THAT SHORTLY AFTER THE IMPLANT PROCEDURE THE PATIENT DEVELOPED PARALYSIS IN THE RIG
THE SYMPTOMS WERE NOT LIKELY DEVICE-RELATED. THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND THERE HAVE BEE
FOUND.
THE CONSUMER REPORTED THAT SHE HAD DIFFICULTY CHARGING THE IMPLANT, IT WOULDN �T FULLY CHARGE. THE PATIENT
IT FROM MORNING UNTIL EVENING BUT IT NEVER FULLY CHARGED THE IMPLANT. THE PATIENT MENTIONED THE SYSTEM WAS
IMPLANT WASN�T CHARGING UP AND SHE HAD TO USE A WHEELCHAIR OR CANE. THE PATIENT HADN �T BEEN RECEIVING P
IT WAS REPORTED THE PATIENT DIDN'T KNOW CAUSE. IT STOPPED WORKING AND THE PAIN STARTED. THE PATIENT SAID SHE H
WOULD JUST DISAPPEAR AFTER BEING CHARGED ALL DAY. THE PATIENT HAD THE HCP CHECK THE CHARGE A FEW TIMES. THE
IS WHEN IT WAS DETERMINED THAT IT SHOULD BE REPLACED. THE ISSUE HAS NOT YET BEEN RESOLVED. THE PATIENT FELL IN T
PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED TO NEVRO THAT SHORTLY AFTER THE PROCEDURE THE PATIENT WAS HOSPITALIZED DUE TO ACUTE PARAPL
WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. THE MANUFACTU
A REPORT WAS RECEIVED THAT FOLLOWING A POSTOPERATIVE PROCEDURE AND WITHIN AN HOUR AFTER IMPLANT PROCEDU
EXPERIENCED TEMPORARY PARALYSIS AND URINARY INCONTINENCE. THE PHYSICIAN CONFIRMED THAT THE SYMPTOMS WER
FOR EXTENSIVE REHABILITATION. MODEL NUMBER/CATALOG NUMBER: SC-1160, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER
A REPORT WAS RECEIVED THAT A NON-CONFIRMED PATIENT POSTED TO (B)(6) THAT HIS IMPLANT CAUSED PARALYSIS; HOWEV
INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THEY EXPERIENCED A SPINAL CORD INJURY AND WA
IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED A BLOOD CLOT AND EXPERIENCED PARALYSIS SHORTLY AFTER TH
RETURNED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES WERE FOUND.
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSC AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT
REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM T
SERIAL NUMBER: (B)(4), LOT NUMBER: (B)(4), DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. A REPORT WAS RECEIV
THE PHYSICIAN BELIEVES THE PARALYSIS IS FROM HEAVY STENOSIS AND IMPLANTATION OF THE PADDLE LEAD. DURING THE IM
REHABILITATION THERAPY.
IT WAS REPORTED TO NEVRO THAT SHORTLY AFTER THE IMPLANT PROCEDURE THE PATIENT DEVELOPED A HEMATOMA AND E
PATIENT HAS RECOVERED WITHOUT SEQUELAE. THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE MANUFACTURING RECOR
IT WAS REPORTED THE PATIENT EXPERIENCED A STROKE WHICH RESULTED IN LEFT SIDE PARALYSIS. ALLEGEDLY, THE STROKE W
AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULA
END OF ITS LIFE (EOL). PATIENT WAS NOW HAVING ISSUES. PATIENT STATED THE BATTERY DIED AT 9 YEARS OLD. THE PATIENT S
DEVICE IMPLANTED. THE PATIENT STATED THAT THEY WERE BECOMING PARALYZED. PATIENT REPORTED THEY COULD BARELY
FROM LACK OF BLOOD FLOW. PATIENT REPORTED THAT THEY CAN BARELY ROLL OVER AND WERE LOSING BLADDER FUNCTION
PARALYSIS WAS POSSIBLE AS IT KILLS THE ROOT OF THE NERVE. PATIENT STATED THE ISSUES BEGAN RIGHT AFTER IMPLANT DI
REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE
(POR) MODE. THE BATTERY WAS NOT OVERDISCHARGED. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS TH
THEY WERE JUST SITTING IN THEIR WHEELCHAIR. THE REP RECONNECTED WITH THE PHYSICIAN PROGRAMMER AND THE POR
AND THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATE
OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVID
NEUROSTIMULATOR (INS) THAT WAS IMPLANTED ON THE SPINAL CORD BETWEEN THE FOURTH AND FIFTH CERVICAL VERTEBR
WAS EXPERIMENTAL. IT WAS REPORTED THAT THE IMPLANT STOPPED CERTAIN SCANS INCLUDING A MUCH NEEDED ULTRASOU
NEVER PASS THE NATURAL WAY. THREE YEARS PRIOR TO (B)(6) 2019, THE IMPLANT FAILED AND A FRACTURED WIRE WAS FOU
PROCEDURE, AND NOW THEY DON'T ATTACH ELECTRODES TO THE SPINAL CORD. THE BATTERY HAD BEEN DEAD THREE YEARS
EXPLOSION, AND BURNS INSIDE THEIR BODY. THE PATIENT HAD FEAR THAT WITH THE BATTERY NOT BEING CHARGED OR WOR
WHEELCHAIR AND FELL ON THEIR FRONT. THE PATIENT WAS LOOKING FOR HELP TO REMOVE THE BATTERY AS SOON AS POSSI
WHEN THEY WOULD BE IN THE (B)(6) AS THEY WERE TRAVELING THERE ON (B)(6) 2019 TO GET CHECKED AFTER REMOVAL OF
IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED PARALYSIS TO THE LEFT SIDE OF BODY AND LOSS OF BLADD
VOLUNTARILY DISCHARGED HERSELF FROM THE FACILITY.
STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM HEMATOMA REPORTED
WHICH TWO FREEDOM-8A TRIAL LEADS (FR8A-TRL-A0 AND FR8A-TRL-B0) WERE IMPLANTED IN THE EPIDURAL SPACE AT THE C
FOR LOW BACK AND LEG PAIN. THERE WERE NO OTHER COMPLICATIONS NOTED DURING THE PROCEDURE. THE PATIENT EXPE
CLINICAL SPECIALIST WITH COMPLAINTS OF NUMBNESS IN HER ARMS AND LEGS. THE CLINICAL SPECIALIST ADVISED THE PATIE
THAT THE PATIENT HAD FLUID BUILD-UP IN HER EPIDURAL SPACE. CONCERNED THAT THE PATIENT HAD A HEMATOMA OR SERO
ANTIBIOTICS. THE PATIENT'S TRIAL DEVICE WAS EXPLANTED WITHOUT COMPLICATION AT THE HOSPITAL. THERE WERE NO CO
TREATING NEUROSURGEON AT THE HOSPITAL HAS CONFIRMED THAT SURGICAL INTERVENTION WILL NOT BE NECESSARY TO T
CLINICIAN'S PROCEDURE COMPARED TO THE TRIAL INSTRUCTIONS FOR USE WITH THE CLINICAL SPECIALIST. THE CLINICAL SPE
FOR USE. THE IMPLANTING CLINICIAN WAS NOT AWARE OF ANY CONCOMITANT MEDICATION OR COMORBIDITIES THAT WOU
UNKNOWN TO HER AND HER CLINICIAN, AND THIS ADVERSE EVENT WAS AN UNANTICIPATED COMPLICATION OF THE TRIAL. E
DETAILED IN STIMWAVE'S RISK MANAGEMENT FILE AS WELL AS APPLICABLE INSTRUCTION FOR USE AND PATIENT-FACING LAB
DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS. STIMWAVE WILL CONTINUE TO TREND EVENTS. THE ROOT
NOR NONCONFORMANCE TO PHYSICAL OR FUNCTIONAL DEVICE SPECIFICATIONS. THE ROOT CAUSE IS LIKELY ATTRIBUTED TO
CORRECTIVE ACTION IS NOT REQUIRED TO REMEDY THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE DID NOT FAIL TO MEET
MITIGATED AS FAR AS POSSIBLE, AND DOCUMENTED IN THE STIMWAVE'S RISK MANAGEMENT FILE. STIMWAVE WAS IN CONST
STIMWAVE CONFIRMED THAT THE TRIAL WAS PERFORMED ACCORDING TO THE IFU, AND THE PRODUCT DID NOT FAIL TO MEE
EVENT WAS AN UNFORESEEN COMPLICATION, LIKELY A RESULT OF A UNKNOWN COMORBIDITY TO THE PATIENT AND THE IMP
DEVICE REPORTING REQUIREMENTS AND RESPONSIBILITIES, STIMWAVE QUALITY AND ITS CHIEF MEDICAL OFFICER HAVE DETE
INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE. STIMWAVE HAS REPORTED THIS AS AN
FR8A-TRL-B0) WERE IMPLANTED IN THE EPIDURAL SPACE AT THE C2 TO C3 LEVEL TO TREAT THE PATIENT'S CHRONIC ARM AND
COMPLICATIONS NOTED DURING THE PROCEDURE. THE PATIENT EXPERIENCED PAIN RELIEF AFTER THE TRIAL AND WAS SENT H
HER ARMS AND LEGS. THE CLINICAL SPECIALIST ADVISED THE PATIENT TO CONTACT HER CLINICIAN WHO IN TURN INSTRUCTED
SPACE. CONCERNED THAT THE PATIENT HAD A HEMATOMA OR SEROMA, THE TREATING HOSPITAL ORDERED TREATMENT THRO
WITHOUT COMPLICATION AT THE HOSPITAL. THERE WERE NO COMPLICATIONS WITH THE EXPLANT PROCEDURE. THE PATIENT
CONFIRMED THAT SURGICAL INTERVENTION WILL NOT BE NECESSARY TO TREAT THE PATIENT'S CONDITION.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: SC-8336-50, SERIAL: (B)(4), DESCRIPTI
DOCUMENTATION FOR THE IPG AND LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EV
REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED TEMPORARY PARALYSIS OF THE LEGS, LOST BLADDER CONTROL, AND
EXPLANT PROCEDURE. THERE WERE NO XRAYS PROVIDED TO CONFIRM THE PLACEMENT OF THE LEADS. THE PATIENT REGAINE
OR IF IT IS DUE TO A LACK OF THERAPY FOLLOWING THE EXPLANT.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TEMPORARY LOWER LIMB PARESIS AFTER THE PATIENT'S PERMANENT SCS
INTO THE EPIDURAL SPACE. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE P
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED SYMPTOMS OF LOWER EXTREMITY PARALYSIS DUE TO A HEMATOM
HEMATOMA. THE PATIENT IS DOING WELL POSTOPERATIVELY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR
WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH
SPECTRA WAVEWRITER IPG KIT. DEVICE DISCARDED BY FACILITY.
IT WAS REPORTED THE PATIENT WAS COMPLAINING OF PARTIAL PARALYSIS FROM THE WAIST DOWN. THE PATIENT UNDERWEN
REPRESENTATIVE INSTRUCTED THE PATIENT TO TURN THERAPY OFF IMMEDIATELY, BUT THE ISSUE PERSISTED. THE PHYSICIAN D
AROUND THE LEAD. THE LEAD WAS EXPLANTED WITH NO ISSUES AND THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR O
INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) AND A PATIENT IMPLANTED FOR SPINAL PAI
BLEEDING IN THE EPIDURAL SPACE SYMPTOMS AND PARTIAL PARALYSIS OF THEIR LOWER EXTREMITIES. THE SYSTEM WAS REM
PRODUCTS: PRODUCT ID 977C165, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE LEAD. IF INFORMATION IS PROVID
ISSUED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS IN HIS LOWER EXTREMITIES AFTER A PERMANENT IMPLANT TH
RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT. IT WAS REPORTED THAT THE PAT
PARALYSIS. THE PATIENT RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE INS AND EVALUATION OF EPIDURAL HEM
FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [MW5081557].
IT WAS REPORTED TO NEVRO THAT THE PATIENT EXPERIENCED PARTIAL PARALYSIS AFTER THE IMPLANT PROCEDURE. IT WAS L
INDICATED THAT THE PATIENT IS CURRENTLY RECOVERING AND USING THE DEVICE TO FIND EFFECTIVE PAIN RELIEF AND THERE
WERE REVIEWED AND NO NON-CONFORMITIES RELATED TO THE NATURE OF THE COMPLAINT WERE FOUND.
PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT P
NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID N
NEUROSTIMULATOR. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE:
MIGNARDOT, J. B., LE GOFF-MIGNARDOT, C. G., DEMESMAEKER, R., KOMI S., CAPOGROSSO, M., ROWALD, A., SE ��EZ, I., CAB
SCHURCH, B., PRALONG, E., BECCE, F., PRIOR, J., BUSE, N., BUSCHMAN, R., NEUFELD, E., KUSTER, N., CARDA, S., VON ZITZEWITZ
WITH SPINAL CORD INJURY. 2 0 1 8. NATURE. VOLUME 5 6 3. 2018-06-08551A (65-93). DOI: 10.1038/S41586-018-0649-2 SUM
CORD STIMULATION NEUROTECHNOLOGIES THAT ENABLED VOLUNTARY CONTROL OF WALKING IN INDIVIDUALS WHO HAD SU
EXTENSIVE REHABILITATION. USING AN IMPLANTED PULSE GENERATOR WITH REAL-TIME TRIGGERING CAPABILITIES, WE DELIV
MOVEMENT. WITHIN ONE WEEK, THIS SPATIOTEMPORAL STIMULATION HAD RE-ESTABLISHED ADAPTIVE CONTROL OF PARALY
PARTICIPANTS REGAINED VOLUNTARY CONTROL OVER PREVIOUSLY PARALYSED MUSCLES WITHOUT STIMULATION AND COULD
IMPROVING NEUROLOGICAL RECOVERY AND SUPPORTING THE ACTIVITIES OF DAILY LIVING AFTER SPINAL CORD INJURY. REPO
WERE MINOR TO MODERATE. 2. 11 ADVERSE EVENTS HAD A POTENTIAL RELATIONSHIP WITH THE PROCEDURE AND WERE THE
PAIN, AND A DECREASE OF STRENGTH IN THE LEGS, AND ANINCREASE SPASTICITY IN THE LEGS. THE AES VARIED FROM AN UNL
SPECIFIC DEVICE INFORMATION PROVIDED.
ON (B)(6) 2014, HE HAD A BOSTON SCIENTIFIC PRECISION SPINAL CORD STIMULATOR IMPLANTED. ON (B)(6) 2014, AFTER COM
THAT THE LEAD HAD BEEN "FRACTURED." THE BATTERY SITE WAS ALSO HOT TO TOUCH AND PAINFUL. IT WAS DETERMINED TH
WAS REPLACED. HE ALSO PLACED NEW PERCUTANEOUS LEAD (16 CONTACT LEAD). AFTER THE REVISION, MY HUSBAND EXPER
THE NATURAL PROGRESSIVE DECLINE THAT IS OCCURRING. IT BEGAN CAUSING HIM MORE PAIN IN HIS NECK, MIDDLE AND LOW
FINGER AND MIDDLE FINGER. THE REINFORCEMENT PLACED BY THE SURGEON WAS ODDLY UNCOMFORTABLE. THE BASE OF H
DISCOMFORT. THE BATTERY OF THE DEVICE IS UNCOMFORTABLE AND IS AT TIMES PAINFUL TO THE TOUCH AND RED AND PUF
DAMAGE. SO WE BEGAN TO SEEK REMOVAL OF THE DEVICE. ON (B)(6) 2015, THE DEVICE WAS REMOVED. (B)(6) HAS BEEN BED
THAN A FEW MINS, CANNOT BEAR WEIGHT ON HIS LEGS AND IS MOSTLY CONFINED TO THE BED. HE CAN NO LONGER TAKE CA
THE PATIENT HAD A TRIAL PROCEDURE PERFORMED ON (B)(6) 2018, IN WHICH TWO (B)(6) WERE IMPLANTED IN THE EPIDURA
BABY ASPIRIN DAILY AS AN OVER THE COUNTER BLOOD THINNER FOR A COMORBIDITY. AT THE END OF THE TRIAL PERIOD, THE
INFORMED THE IMPLANTING CLINICIAN THAT HE STARTED EXPERIENCING NUMBNESS AND WEAKNESS IN HIS LEGS. AN MRI EV
PATIENT HAD A HEMATOMA OR SEROMA, THE IMPLANTING CLINICIAN ORDERED IMMEDIATE TREATMENT THROUGH (B)(6) 20
REPORTED TO STIMWAVE ON (B)(6) 2018, BY STIMWAVE CLINICAL SPECIALIST. THE PATIENT HAD A TRIAL PROCEDURE PERFORM
TO T9 LEVEL TO TREAT THE PATIENT'S LOW BACK AND LEG PAIN. DURING THE PROCEDURE, THE IMPLANTING CLINICIAN NOTED
TAKES A BABY ASPIRIN DAILY AS AN OVER THE COUNTER BLOOD THINNER FOR A COMORBIDITY. THERE WERE NO OTHER COM
AT THE END OF THE TRIAL PERIOD, THE PATIENT REPORTED SIGNIFICANT PAIN RELIEF WITH THE DEVICE AND HIS TRIAL DEVICE
AND WEAKNESS IN HIS LEGS. AN MRI EVALUATION (DATE IS UNKNOWN TO STIMWAVE) REVEALED THAT THE PATIENT HAD FLU
IMMEDIATE TREATMENT THROUGH (B)(6) 2018 TO RESOLVE THE ISSUE. TREATMENT INCLUDES IV ANTIBIOTICS. THE PATIENT IS
STIMWAVE QUALITY AND MANAGEMENT REVIEWED THE IMPLANTING CLINICIAN'S PROCEDURE COMPARED TO THE TRIAL INS
THE PRODUCT INSTRUCTIONS FOR USE. THE IMPLANTING CLINICIAN WAS AWARE OF THE PATIENT'S ASPIRIN REGIMEN FOR HI
PATIENT'S COMORBIDITY WAS AN UNANTICIPATED COMPLICATION FOLLOWING THE TRIAL. EPIDURAL HEMORRHAGE, HEMATO
MANAGEMENT FILE AS WELL AS APPLICABLE INSTRUCTION FOR USE AND PATIENT-FACING LABELING AND IS MITIGATED AS FA
PERFORMANCE OR SAFETY SPECIFICATIONS. STIMWAVE WILL CONTINUE TO TREND EVENTS. THE ROOT CAUSE OF THE COMPL
NONCONFORMANCE TO PHYSICAL OR FUNCTIONAL DEVICE SPECIFICATIONS. THE ROOT CAUSE IS LIKELY ATTRIBUTED TO THE T
ISSUE. CORRECTIVE ACTION IS NOT REQUIRED TO REMEDY THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE DID NOT FAIL TO
KNOWN RISK, MITIGATED AS FAR AS POSSIBLE, AND DOCUMENTED IN THE STIMWAVE'S RISK MANAGEMENT FILE. STIMWAVE
STIMWAVE CONFIRMED THAT THE TRIAL WAS PERFORMED ACCORDING TO THE IFU, AND THE PRODUCT DID NOT FAIL TO MEE
EVENT WAS AN UNFORESEEN COMPLICATION AS A RESULT OF THE PATIENT'S ASPIRIN REGIMEN FOR COMORBIDITY. STIMWAV
REQUIREMENTS AND RESPONSIBILITIES, STIMWAVE QUALITY AND ITS CHIEF MEDICAL OFFICER HAVE DETERMINED THAT THIS
PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE. STIMWAVE HAS REPORTED THIS AS AN ADVERSE EVENT TO THE UNITED S
PT HAD SPINAL CORD STIMULATOR INSERTED ON (B)(6) 2018. RETURNED TO HOSP (B)(6) 2018 WITH LOWER EXTREMITY PARA
THE DEVICE WAS EXPLANTED BUT NOT RETURNED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFOR
EPIDURAL HEMATOMA. THE LEAD WAS EXPLANTED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGAR
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS)
PERMANENT IMPLANT IN 2004, HOWEVER IT WENT BADLY WHEN THEY GOT THE PERMANENT INS. THE PATIENT NOTED THEY
HASN'T WORKED. THE PATIENT SAID THAT BECAUSE THEY WERE IN A WHEELCHAIR (UNRELATED TO THE DEVICE), THE INS KEPT
ISSUE, BUT THE PATIENT DID NOT PROVIDE A DATE. THE PATIENT SAID THEIR REASON FOR CALLING WAS TO GET PHYSICIAN LIS
FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA SHORTLY AFTER THE IMPLANT PROCE
PLACED INTO THE SUBCUTANEOUS TISSUE. SURGICAL DECOMPRESSION WAS PERFORMED, THE LEAD WAS PLACED BACK INTO
AND IS CURRENTLY USING THE DEVICE WITH EFFECTIVE PAIN RELIEF. THE DEVICE WAS NOT EXPLANTED. THE MANUFACTURING
INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN IMPLAN
AND THAT IT WAS NOT UPRIGHT/HORIZONTAL WHICH HAS MADE ADAPTIVE STIMULATION (AS) A CHALLENGE. THE REP PROGR
TO SET THE UPRIGHT POSITION BUT WHEN THEY SIT THE INS ROLLS UNDERNEATH THEIR BUTTOCKS. ON (B)(6) 2018 THE REP S
THEY WERE UNABLE TO GET 'COMPLETE SCREEN.' THE REP THEN TRIED COMPLETELY CLEARING AS SETTINGS AND TO START O
COMPLICATIONS WERE REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A P
CHECKED, THE IMPEDANCE WAS HIGH. IT WAS NOTED THAT THE PATIENT USED A WHEELCHAIR AND CONSTANTLY MOVED, BE
DECIDED TO REMOVE THE DEVICE BECAUSE THEY DIDN'T HAVE A CHANGE WITH OR WITHOUT STIMULATION. THE ISSUE WAS
SERIAL/LOT #: (B)(4), UBD: 25-NOV-2018, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPO
THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN
REGARDING MEDICAL HISTORY. IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE PARALYSIS IN HER LOWER EXTRE
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE CAUSE OF THE STIMULATION CHANGING ON I
REPORTED. THE CONSUMER REPORTED THAT THEY DON'T THINK THE CONTROLLER IS WORKING PROPERLY. IT WAS CLARIFIED
STIMULATION TO AROUND 12 AND 1-5 MINUTES LATER THE PATIENT REPORTED THE INTENSITY DECREASED TO 1 AND SHE CO
THE CONSUMER TRIED USING AA BATTERIES INSTEAD OF THE BATTERY PACK BUT THE ISSUE DID NOT RESOLVE. TROUBLESHOO
TRAUMAS AND THE CONSUMER NOTED THAT THE PATIENT WAS MOSTLY IMMOBILE IN A WHEELCHAIR AND WOULD USE A W
WAS UNKNOWN IF ADAPTIVE STIMULATION OR CYCLING WAS ENABLED. IT WAS CONFIRMED THAT THE PATIENT DID NOT CHA
THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) AND PATIENT. THE HCP INDICATED THAT
THEM. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THEIR NEED FOR INFORMATION WAS THE C
INFORMATION, WHICH RESOLVED THE ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. INFORMATIO
REPORTED THAT THE PATIENT USED ADAPTIVE STIMULATION AND USUALLY USED THE UPRIGHT POSITION BECAUSE THEY WER
IN THE OFFICE BECAUSE THEY COULDN'T GET ONTO THE BED AND THEY WANTED TO ADJUST IT AT HOME. THE PATIENT WASN
NUMBERS AND ONLY SAW LINES. IT WAS REVIEWED HOW TO ADJUST EACH PROGRAM SEPARATELY. THE PATIENT REPORTED TH
WERE LAYING DOWN. THE STIMULATION ISSUE WAS RELATED TO A POSITIONAL MOVEMENT (WHEN THE PATIENT WAS LAYING
HOW TO ADJUST AND SAVE THE SETTINGS BY STAYING IN THE POSITION FOR 3-5 MINUTES; THE PATIENT WAS IN THE UPRIGHT
WAS REVIEWED THE PATIENT WOULD NEED TO ADJUST WHILE LAYING DOWN AND WAIT UNTIL THE PROGRAMMER SHOWED
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON (B)(4)2018 INDICATING THAT
WERE REPORTED/ARE ANTICIPATED. INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFA
MIGRATED. THE PATIENT IS WHEELCHAIR BOUND AND BENDS AND TWISTS FREQUENTLY TO GET IN AND OUT OF THE CHAIR. T
AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION WAS PLANNED. NO SYMPTOMS OR FURTHER COMPLICATIONS WE
:977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977
INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE
INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH A WIRELESS
PATIENT COULD NOT FEEL OR MOVE THEIR LEGS POST TRIAL LEAD PLACEMENT. IT WAS UNKNOWN IF THERE WERE ANY ENVIR
HOURS. THE FEELING IN THEIR LEGS WAS IMPROVING, BUT ONLY SLIGHTLY, SO THE LEADS WERE REMOVED. AFTER LEAD REMO
PATIENT LEFT AGAINST MEDICAL ADVICE. THE ISSUE WAS NOTED TO BE RESOLVED AND THE PATIENT WAS ALIVE WITH NO INJU
PRODUCTS: PRODUCT ID: 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: SCREEN
RELEVANT DEVICE(S) ARE: PRODUCT ID: 977D260, SERIAL/LOT #: (B)(4), UBD: 01-AUG-2022, (B)(4); PRODUCT ID: 977D260, SER
IT WAS REPORTED TO NEVRO THAT A FEW DAYS AFTER THE IMPLANT PROCEDURE, THE PATIENT DEVELOPED TEMPORARY PAR
FOUND AN EPIDURAL HEMATOMA. THE PATIENT WAS DOING PHYSICAL THERAPY AND REGAINING MOVEMENT IN THE LEGS. F
RETURNED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURE REPRESENTATIVE REGARDING A PAT
PARALYSIS IN THEIR LEGS. THE PATIENT WENT TO THE EMERGENCY ROOM 2 DAYS AFTER BEING IMPLANTED. IT WAS NOTED TH
NOTHING TO INDICATE AN ADVERSE REACTION DURING IMPLANT. THE CAUSE WAS UNKNOWN AND THE SYSTEM WAS TO BE E
(4), UBD: 09-AUG-2022, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUE
IT WAS REPORTED FOLLOWING A PERMEANT IMPLANT ON (B)(6) 2018, THE PATIENT DEVELOPED A BLOOD CLOT AT THE LEAD
UNKNOWN) WHERE THE BLOOD CLOT WAS REMOVED RESOLVING THE ISSUE. IN THE EVENT THE DEVICE IS RETURNED TO THE
TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY
A REPORT WAS RECEIVED THAT FOLLOWING THE PLACEMENT OF THE TEMPORARY LEADS FOR A TRIAL PROCEDURE DURING T
PHYSICIAN PULLED THE TEMPORARY LEADS AND SENT THE PATIENT TO THE EMERGENCY DEPARTMENT. IT WAS REPORTED BY
ARACHNOIDITIS, AND THE PHYSICIAN INDICATED THAT IT MAY BE RELATED TO THE NEEDLE OR THE LEAD BUT IT CANNOT BE C
IMPROVE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: SC-2316-50E; SERIAL: (B)(4
ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE S
IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A PERMANENT SCS SYSTEM ON (B)(6) 2018. POSTOPERATIVE, THE PAT
WHEREIN THE SYSTEM WAS EXPLANTED. DURING THE EXPLANT, THE PHYSICIAN DISCOVERED A HEMATOMA. NEUROMONITOR
TO REDUCE THE CHANGES OF BLEEDING TO OCCUR AGAIN. IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER,
MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT RE
THE CONSUMER REPORTED THAT SINCE HER FALL SHE WAS UNABLE TO TURN HER STIMULATION ON BECAUSE THE VIBRATION
PATIENT EXPLAINED THAT SHE FELL AND BROKE HER HIP AND HAD TO HAVE A HIP REPLACEMENT. THE PATIENT ALSO HAD NER
OF HER BACK AND IT WAS DETERMINED IT WAS A PROBLEM WITH HER EQUILIBRIUM SO SHE WAS PUT ON A DIZZY PILL AND W
STIMULATION ALL THE TIME BUT NOW SHE COULDN'T DUE TO THE FALL. THE PATIENT WAS CURRENTLY IN A WHEELCHAIR AND
WILL BE ISSUED.
IT WAS REPORTED THE PATIENT EXPERIENCED A HEMATOMA AT T8 LEAD SITE AS WELL AS WEAKNESS AND PARALYSIS IN BOTH
LOCATION. INTRA-OP TESTING REVEALED LEADS WERE WITHIN NORMAL RANGE. HOWEVER PARALYSIS STILL RESIDE POST REV
RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGA
IT WAS REPORTED THE PATIENT EXPERIENCED PARALYSIS IN BOTH LEGS AS WELL AS WEAKNESS AND A HEMATOMA AT T8 LEAD
LOCATION. INTRA-OP TESTING REVEALED LEADS WERE WITHIN NORMAL RANGE. HOWEVER, PARALYSIS STILL RESIDE POST REV
RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGA
BOTH LEGS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS EXPLANTED. THE PATIENT IS RECOVERING IN
LOWER EXTREMITIES. THE DEVICE WAS EXPLANTED AND THE PATIENT IS RECOVERING IN THE ICU. THERE HAVE BEEN NO REPO
INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED FOR SPI
DURING THE INITIAL SETUP OF ADAPTIVE STIMULATION, THE INS WAS SHOWING UPRIGHT WHEN THE PATIENT WAS LYING DO
POCKET DURING THE POSITIONAL CHANGES. THEY MENTIONED THAT LYING LEFT AND LYING RIGHT DON �T APPEAR TO BE SE
OVERLAPPED. THEY STATED THAT THE PATIENT REPORTED THEY HIT THEIR INS POCKET ON A WHEELCHAIR A FEW WEEKS AGO
WITH THE PATIENT IN A FEW MORE WEEKS TO ATTEMPT ORIENTATION AGAIN. THEY MENTIONED THAT THE THOUGHT WAS TO
A REPORT WAS RECEIVED THAT TWO DAYS FOLLOWING A PERMANENT IMPLANT PROCEDURE THE PATIENT WAS EXPERIENCIN
EPIDURAL HEMATOMA AND NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND POSTOPERATIVE
INFORMATION CAN BE OBTAINED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC
EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE M
OCCURRED DURING MANUFACTURING.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER AND MANUFACTURER'S REPRESENTATIVE REGARDING A PATIE
THAT THE PATIENT WAS EXPERIENCING ICY COLD SENSATION AND FELT LIKE A BEE WAS STINGING HER WHEN STIMULATION W
STRESSING FROM SIDE EFFECTS WITH TRIGGERED HEADACHES. INTERMITTENTLY FOR THE PAST 2 WEEKS. THE CALLER REACHE
05/25/2018 FROM A MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WAS HAVING FACIAL PARALYS
CONTORTIONS WHEN STIMULATION WAS TURNED ON. IT WAS REPORTED A BUZZING SENSATION CONTINUED AFTER DEVICE W
WAS REPORTED THE ISSUE STARTED A WEEK AND HALF AGO AFTER A FALL. NO FURTHER COMPLICATIONS WERE REPORTED/A
NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT
DATE OF EVENT IS YEAR VALID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. INF
SPINAL PAIN AND POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT PATIENT WAS IN A WHEEL CHAIR DUE T
STATING PATIENT RECEIVED THEIR PROGRAMMER ORDER AFTER 5 WEEKS AND THEY WERE UPSET WITH HOW LONG IT TOOK.
MONTH AND A HALF DUE TO BEING WITHOUT STIMULATION. PATIENT ALSO HAD TO BE PUT ON PAIN MEDICATIONS BECAUSE
REPRESENTATIVE GOT THE RECHARGER WORKING YESTERDAY BECAUSE THEY WERE HAVING TROUBLE WITH IT. BUT LATER AS
GETTING COUPLING BARS BUT THEN THEY GOT THEM AND THEY CHARGED FOR 8 HOURS BUT THE INS GOT BARELY HALF A CH
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE CAUSE
WAS AVAILABLE. NO ACTIONS HAVE BEEN TAKEN TO RESOLVE THE ISSUE OF THE WIRES BEING IN BEING IN FRONT OF THE INS
WAS UNABLE TO STAND OR BARE WEIGHT DUE TO THEIR MEDICAL HISTORY (THEY WERE WHEELCHAIR BOUND). THE PROVIDE
INFORMATION WAS RECEIVED FROM A MANUFACTURER �S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED W
REPRESENTATIVE NOTICED THAT THE WIRES APPEARED TO BE IN FRONT OF THE INS. IT WAS PAINFUL WHEN THEY TRIED TO CH
(B)(4) LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A
977A260, SERIAL/LOT #: (B)(4), (B)(6), (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL B
THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER HAS LIMITED INFORMATION R
REPORTED. ABBOTT DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. IT WAS REPORTED THE PATIENT HAS
INTERVENTION TO ADDRESS THE REMOVAL OF THE HEMATOMA AND EXPLANT OF THE SCS SYSTEM. THE PATIENT HAS PARTIAL
NEVRO IS AWAITING THE RETURN OF THE EXPLANTED DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NO
AFTER THE IMPLANT PROCEDURE, RESULTING IN PARALYSIS. SUBSEQUENTLY, THE PHYSICIAN EXPLANTED THE DEVICE ALTHOU
CENTER.
1992 AFTER SEEING 12 DRS OVER THE NEXT SIX YEARS SHE SAW A DOCTOR (B)(6), GASTROENTEROLOGIST WHO HAD THE WES
KEPT INCREASING AND SHE BECAME PHYSICALLY DISABLED AND WAS UNABLE TO PERFORM HER TEACHING FOURTH GRADE A
CHARGING US (B)(6) EVERY SIX WEEKS FOR THE WESTERN TITER TEST THAT HE HAD PERFORMED PLUS (B)(6) DAILY FOR THE A
ANYTHING. I WAS AFRAID TO MOVE AT TIMES AS IT WOULD SET MY HEART OFF SO, I DECIDED NOT TO WORK FOR THREE YEAR
BEGINNING OF THE BUNDLE OF HIS RESIDES, IF I REMEMBER CORRECTLY. MY WIFE IN 1998 SPENT THREE WEEKS IN THE PSYCH
FORWARD TO THE SPRING OF 2016 (I HAVE SOME 15 TO 17 PAGES OF HER MEDICAL HISTORY BETWEEN 1998 TO 2016). DR (B)
INJECTIONS WHICH WORKED FOR TWO MONTHS, BUT DR (B)(6) HAD TO WAIT THREE MONTHS BEFORE PERFORMING THESE I
(B)(6) TO IMPLANT A SPINAL CORD STIMULATOR AS THAT WOULD PROBABLY WORK BETTER THAN HER INJECTIONS. ON (B)(6)
BELT THAT HELD THE STIMULATOR IN PLACE. FOR FIVE DAYS IT WORKED AS MY WIFE'S PAIN LEVEL AT THAT TIME HAD BEEN BE
REMOVE THE WIRES DUE TO POSSIBLE SEPSIS AND RECOMMENDED DR (B)(6), TO IMPLANT THE NEVRO HF10 SPINAL CORD ST
THE SURGERY ENDED. AT FIRST, (B)(6), RN FROM NEVRO INFORMED ME AT APPROX 2:20PM THAT EVERYTHING WAS FINE WITH
WIFE WOULD BE GOING HOME THE FOLLOWING DAY. ON (B)(6) 2016, (B)(6). NURSE PRACTITIONER (B)(6), MSN CRNP CHANGE
HOWEVER, THE FRONT DESK COULD ONLY SCHEDULE IT IN TWO WEEKS. ALSO, MY WIFE WAS IN PAIN AND (B)(6) SAID IT WAS
PROBLEM). THE FOLLOWING DAY (B)(6) WAS IN SO MUCH PAIN THAT I TOOK HER TO (B)(6) HOSPITAL ER WHO AFTER FOUR HO
REQUESTED A GURNEY AFTER SITTING IN THEIR WHEEL CHAIR FOR A HALF AN HOUR AS IT WAS TOO PAINFUL. THE RN SAID SH
HOWEVER, THE RN SAID IT WAS SEPTIC. SO, I TOLD HER GIVE ME AN ANTISEPTIC SPRAY BOTTLE WITH A CLOTH AND A FRESH B
CARE. AFTER 3 HRS, THE RN GAVE MY WIFE SOME RESTORIL WHICH PUT (B)(6) TO SLEEP FOR ABOUT TWENTY MINUTES. THEN
AND WHAT WAS THE PURPOSE OF DEALING WITH (B)(6) AS THEY DID VERY LITTLE TO HELP WITH (B)(6)'S PAIN. THEREFORE, W
TO INSPECT A 2" X 3" SAC (BUBBLE LIKE) THAT HAD FORMED ON HER BACK. AFTER TAKING X-RAYS SHE SAID NOTHING COULD
(6), CHIEF NEUROSURGERY, ASSESSED THE NOW 3" X 5" BUBBLE AND STATED NOTHING COULD BE DONE. ON (B)(6) 2018, (B)(6
HELPED PAIN IN THE NECK AREA TO LESSEN. NEVRO REP INFORMED US TO TRY PROGRAM 1 AT LEVEL 2 FOR 3 DAYS, THEN GO
SEEMED TO MATTER. DR (B)(6) SCHEDULED US FOR (B)(6) 2018 VISIT AND THEN CANCELLED IT (NOT SURE WHEN) TO (B)(6) 20
TWO PAGE LETTER TO CEO OF (B)(6) WITH COPIES TO DEAN (B)(6) WHERE DR (B)(6), (B)(6)'S CURRENT PAIN MGMT DR WHO PR
OF (B)(6) AND THE CATCH 22 OF OBTAINING GOOD PAIN MGMT DRS. THAT LETTER FORCED DR (B)(6) TO RESCHEDULE FROM (B
109 PTS SO FAR THIS DAY WHICH IS ANOTHER LIE, AS I THOUGHT GOING HOME HE WOULD HAVE SEEN AN AVERAGE OF 12 PT
WORKING THEIR PEOPLE SO HARD THAT THEY HAVE TO LIE. DR (B)(6) BEGAN BY STATING THAT I WRITE NASTY LETTERS WHICH
DOWN AN INTERN THAT WOULD DO NOTHING, SO I DIDN'T THINK HE REALLY CARED ABOUT MY WIFE AND THAT IS WHY WE N
INFORMED US OF A DR (B)(6) WHO WOULD GLADLY OPERATE ON MY WIFE'S BACK AS SHE WAS TURNING INTO A PRETZEL AND
CRAZY ENOUGH TO TRY ANYTHING AS IT WOULD TAKE MANY HRS EXCEPT MY WIFE WOULD PROBABLY DIE ON THE OPERATIN
AT THE VERY BEGINNING OF THE SESSION, SHE WOULD NEVER HAVE BACK SURGERY EVER AGAIN AS IT WAS TOO PAINFUL. OB
(B)(6) TO EVER TOUCH HER AGAIN, AS HE DID A POOR JOB IN SO MANY WAYS AFTER THE OPERATION AND MAY BE DURING TH
I'M NOT GOING TO RECHARGE THE NEVRO HF10 ANY MORE UNLESS YOUR PAIN BECOMES WORSE AND YOU THINK YOU REQU
STATED IT WAS AT LEVEL SIX AND AT TIMES BUT RARELY AT 4. SHE FURTHER STATED THAT THE PAIN THAT CROSSED HER LOWER
RESIDES JUST IN THE SPINAL COLUMN AT SIX AND NOT EIGHT. OVER THE PAST FOUR MONTHS, I NOTICED THAT SHE WOULD JU
REDUCED IN SIZE THAT SITS ON TOP OF T9 TO L5 TO A 1-1/2" TO 3" AREA AND DOES NOT SWELL UP LIKE IT INITIALLY DID LAST
MORE LOCALIZED IN ONE AREA, BUT THAT PROBABLY WILL CHANGE. ALSO, I HAVE BEEN ADMINISTERING .08ML OF FORTEO IN
PAIN IN HER LEFT FEMUR FOR SOME TIME AND IT BROKE ON (B)(6) 2011. HER OSTEOPOROSIS SEEMS TO BE IN CHECK BUT SHE
PUT IN A DIFFERENT NEVRO HF10 SPINAL CORD STIMULATOR MAY BE, IT WILL HELP HER GO BACK TO LEVEL 2 TO 3 PAIN.
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37751 SERIAL (B)(4), PROD
INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4) (CON): INFORMATION WAS REC
THAT THE INS WON�T TAKE A CHARGE AND �IT MESSED ME UP �. THE PATIENT REPORTED THAT THEY CANNOT BALANCE T
PUT THE STIMULATOR IN. THE PATIENT REPORTED THAT THEY CANNOT CONTROL THEIR HANDS AND HAVE LOSE CONTROL OF
EVERYTHING AND CAN�T CONTROL TWITCH. THE PATIENT REPORTED THAT THEY HAVE BAD HARMS AND CANNOT REACH BA
PATIENT REPORTED THAT THEIR �JOINT WAS MESSED UP �. THE PATIENT REPORTED THAT THEY CAN �T GET THE RECHARGE
WALL. DURING THE REPORT, THE PATIENT OBTAINED THE PATIENT PROGRAMMER AND CONNECTED WITH THE INS WHICH SHO
BATTERY LOW ON SCREEN�. THE PATIENT WAS INSTRUCTED TO START CHARGE WITH THE GREEN BUTTON, BUT THE PATIENT
A REPORT WAS RECEIVED THAT THE DURING THE TRIAL PROCEDURE THE PATIENT SUFFERED A STROKE AND WAS IN THE INTEN
WAS SUSPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD RIGHT SIDED PARALYSIS DUE TO STROKE
SERIAL #: (B)(4), DESCRIPTION: TRIAL LINEAR 3-6 LEAD, 50CM.
INFORMATION WAS RECEIVED FROM THE PATIENT AND MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH
IMPLANT BATTERY WENT DEAD TRYING TO GET THE RECHARGER TO CONNECT WITH IT, BUT THEY HAD NOT BEEN SUCCESSFUL
DESCRIBED THE REPOSITION ANTENNA SCREEN. IT WAS REPORTED THAT THIS BEGAN AT THE END OF (B)(6) 2018. THE PATIENT
CHANGED THE BATTERIES OUT EARLIER THIS MORNING. THE PATIENT HAD A RECHARGEABLE DEVICE AND THEY WERE NOT AB
2018. THEIR LAST SUCCESSFUL RECHARGE SESSION WAS IN (B)(6) 2018. THE PATIENT PLACED THE PATIENT PROGRAMMER DIR
REDIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER TO RESOLVE THE POTENTIAL OVERDISCHARGE. ADDITIONAL
NOT RECHARGE. THEY STATED THAT THEY HAD AN MRI SCHEDULED FOR TOMORROW AND THE CENTER TOLD THEM THAT THE
SOUNDED LIKE THE ISSUE WAS DUE TO THE PATIENT �S NON-COMPLIANCE. IT WAS REPORTED THAT THEY WOULD MEET WIT
NOT RESOLVED. NO SURGICAL INTERVENTION OCCURRED OR HAS BEEN PLANNED. NO FURTHER COMPLICATIONS WERE REPO
PATIENT AT THE PHYSICIAN�S OFFICE, BUT THE DEVICE WAS NOT ABLE TO BE RECOVERED FROM OVERDISCHARGE. THE REP S
THE DEVICE IN OVER 1.5 YEARS DUE TO NECK SURGERY, AND REHAB DUE TO COMPLICATIONS FROM THE SURGERY THAT RESU
ANTICIPATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT. IT WAS REPORTED THAT THE PAT
REPORTED ON (B)(6) 2018 THAT THE PATIENT WASN'T USING THE SYSTEM BECAUSE IT WAS CAUSING PARALYSIS IN THEIR LEG
MONTHS AND REPORTED FEELING PARALYSIS IN THEIR LEGS. THE PATIENT REPORTED THIS TO THEIR PHYSICIAN AND WAS TOL
EVER SINCE. IT WAS REVIEWED THAT THE INS WAS LIKELY OVERDISCHARGED, AS IT HADN'T BEEN IN USE FOR ABOUT TWO YEA
THE CLINIC BECAUSE THEY HAD PAIN. THE HCP STATED THAT THE PATIENT WAS IMPLANTED IN 2016 AND STOPPED USING THE
HOWEVER, THE HCP NOTED THAT THE PARALYSIS WAS A TEMPORARY THING, AS THE PATIENT WAS �OBVIOUSLY WALKING �
SPOKE TO THE PATIENT A FEW WEEKS PRIOR AND THAT THE PATIENT HAD PLANNED ON GETTING THE INS REMOVED. NO FURT
A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A CONSUMER AND A REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANT
INS WAS IMPLANTED SO THE DEVICE WAS EMERGENTLY EXPLANTED. THE PATIENT WAS STILL HAVING BILATERAL LEG WEAKNE
INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF N
WAS MUCH STRONGER THAN IT WAS BEFORE. THE PATIENT MENTIONED THAT IT USED TO NORMALLY BE AT 3V, BUT NOW THE
THE IMPLANT OF THE SCS SYSTEM. THE PATIENT REPORTED THAT THEIR SHOULDER HAS SUBLUXATION DISLOCATION DUE TO T
REPORTED THAT THEY WERE REGAINING FEELING IN THEIR VOCAL CORD, WHICH WAS ALSO PARALYZED. THE PATIENT REPORT
FURTHER COMPLICATIONS ARE ANTICIPATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL
INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A P
PLACEMENT IN THE CERVICAL VERTEBRAE, THE PATIENT COMPLAINED OF NUMBNESS AND PARALYSIS OF THE UPPER LIMBS, S
ADDITIONAL LAMINOPLASTY AND REPOSITION OF THE LEAD WHICH WAS CONFIRMED TO BE DISPLACED TO LOWER WERE PLA
LAMINOPLASTY AND REPOSITION OF THE LEAD WERE POSTPONED, AND PERFORMING SOME TREATMENT WILL BE CONSIDER
AVAILABLE. NO TELEMETRY DATA AVAILABLE, AS THE EVENT HAD NO RELATION WITH TELEMETRY DATA BECAUSE THE ISSUE W
INTERVENTION WAS PLANNED, BUT NOT SCHEDULED. THE PATIENT WAS ALIVE WITH INJURY. NO FURTHER COMPLICATIONS W
(B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A290, SERIAL/LOT #
FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATO
BUTTOCK ON THE RIGHT SIDE. THE PATIENT STATED IT IS TERRIBLY PAINFUL. THE PATIENT STATED HE CAN'T EVEN WALK HE HAS
PATIENT THEN STATED IT IS VERY HARD TO STAND UP AND HE HAS TO PUT ALL HIS WEIGHT ONTO THE LEFT SIDE. THE PATIENT
PATIENT NOTED HE LOVE THIS THERAPY AND HE IS NORMALLY A VERY HAPPY CUSTOMER. THE PATIENT ALSO STATED WITHOU
ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT MENTIONED HE CAN'T GET HIS STIMULATION TO "CLAM DOW
STIMULATION LOW ENOUGH TO BE COMFORTABLE, AND HAS TO KEEP TURNING STIMULATION OFF AND ON. THE PATIENT STA
FEELING TO WHERE A "MOTOR RACES" WHERE YOU FEEL "LIKE A ZOOM" STATING STIMULATION IS"NOT A STEADY FLOW". THE
OFF AND SIT DOWN BECAUSE MY FEET ARE BURNING". THE PATIENT STATED WHEN HE FIRST GOT HIS IMPLANT, HE LEFT STIM
STATED THE INS "WAS LIKE MAGIC". THE PATIENT STATED HE COULD WALK AND HIS PAIN LEVEL WAS BASICALLY GONE. THE PAT
UNDERSTANDING HE WON'T BE 100% PAIN FREE, BUT BETTER. THE PATIENT STATED HE TALKED TO THE PAIN CLINIC AND THEY
INS AND THE PATIENT TOLD THE HCP STIMULATION IS REALLY ROUGH AND THERE SHOULD BE AN ADJUSTMENT SOMEWHERE
FURTHER INFORMATION WAS REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE I
AND THEY STATED IT ALMOST KNOCKED THEM OUT OF THEIR WHEELCHAIR. THE PATIENT NOTED THEY MAY HAVE HIT THE UP
REPROGRAMMING. THE PATIENT STATED THEY THOUGHT THEY LEANED ON THE INCREASE BUTTON AND IT SURGED STIMULAT
WERE LOSING THEIR BREATH AND EXPERIENCING KIDNEY CRAMPS AND EVERYTHING. THE PATIENT NOTED THE DEVICE JUST S
THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED ON (B)(6) 2018 FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEU
WORKING AT ALL FOR 2 DAYS, THE CONSUMER GOT ALL 8 BARS AND WOULD BE CHARGING FOR 2 HOURS BUT THE IMPLANTA
NOT CHARGE THE INS AT ALL. THE MANUFACTURER REPRESENTATIVE WAS TOLD ABOUT THE ISSUE TODAY BUT COULD NOT RE
WORK AND THE PATIENT HAD NEVER BEEN ABLE TO CHARGE THE INS BY WEARING THE BELT. THE PATIENT HAD TO HOLD THE
UNIT BECAUSE THEY HAD TO DEAL WITH THE MAINTENANCE OF RECHARGING. THE TRIAL DID NOT REQUIRE RECHARGING AN
PUMP WHERE THERE WAS NO CHARGING REQUIRED. THE DISSATISFACTION WITH THE NEED TO CHARGE HAD BEEN SINCE IMP
CHARGING ISSUES STARTED IN 2018 AT THE END OF (B)(6) OR EARLY IN (B)(6). IT WAS REPORTED THAT IT STOPPED WORKING A
CERTAIN WAY. THIS STARTED A COUPLE OF DAYS BEFORE THE PATIENT HAD A LOSS OF THERAPEUTIC BENEFIT STARTING ON (B)
WHEELCHAIR OR USED A WALKER. THE PUMP HELPED A GREAT DEAL TO IMPROVE THEIR QUALITY OF LIFE. NOW THE PATIENT
LOSS OF THERAPEUTIC BENEFIT. IT WAS CONFIRMED THAT STIMULATION WAS OFF. NO FURTHER COMPLICATIONS WERE REPO
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A CONSUMER REGARDING A PATIENT WH
THE INS HAS NOT BEEN TURNED ON. NO TROUBLESHOOTING WAS DONE AS OF YET. REP STATED THAT THE PATIENT WAS IMPL
APPOINTMENT THE DAY OF THE REPORT TO HAVE THE DEVICE PROGRAMMED AND REPORTED THE SENSATION IN LEGS. REP W
THE NERVE. EVALUATION AND IMAGING WAS RECOMMENDED. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL
DEVICE WAS OFF BY USING THE PATIENT PROGRAMMER. IT WAS UNKNOWN WHAT THE CAUSE WAS. PATIENT STATED THAT PA
CONSUMER ON (B)(6) 2018 REPORTING THAT THE LEG TINGLING WENT AWAY 2 DAYS LATER. THE PATENT WAS PROGRAMMED
HAD BEEN AGITATED, HAD WEAKNESS IN LEGS, AND ABDOMINAL CRAMPS. THE INS WAS SHUT OFF AT THE TIME. SINCE MARC
IN A WHEELCHAIR AND UNABLE TO STAND. THEIR RIGHT LEG WAS BEING ADDRESSED BY PHYSICAL THERAPY AND WAS BETTER
THE HEALTH CARE PROVIDER (HCP) AND MANUFACTURER REPRESENTATIVE ON (B)(6) 2018. NO FURTHER COMPLICATIONS WE
REGARDING MEDICAL HISTORY. IT WAS REPORTED THE PATIENT LOST WEIGHT AND THE IPG WAS RUBBING ON THE WHEELCHA
IPG FROM THE RIGHT LOW BACK TO RIGHT LOWER QUADRANT.
THE PATIENT HAD PAIN IN THE BASE OF THEIR BACK SO BAD THAT THEY WERE UNABLE TO WALK AND WERE IN A WHEELCHAIR
NOT BELIEVE THEY HAVE HAD ANY REPROGRAMMING SESSIONS SINCE IMPLANT. THE PATIENT CALLED THEIR HEALTHCARE PRO
RECHARGED IN A WHILE AND SAID THE RECHARGER WAS COMPLETELY DEAD. THE PATIENT WAS GOING TO CHARGE THE RECH
MONTHS AGO. IT WAS UNKNOWN WHEN THE LAST TIME THE PATIENT FELT STIMULATION WAS. THE PATIENT STOPPED USING
NEVRO IS AWAITING THE RETURN OF THE EXPLANTED DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NO
EXTREMITIES A FEW MONTHS AFTER IMPLANT. THE DEVICE WAS EXPLANTED FOR COMPREHENSIVE TESTING ON THE PATIENT.
THE PATIENT EXPERIENCED SOME OF THE SYMPTOMS PRE-IMPLANT, SUCH AS CRAMPING. NEVRO ATTEMPTED TO OBTAIN ADD
REGARDING MEDICAL HISTORY. IT WAS REPORTED THE PATIENT DEVELOPED A HEMATOMA AT THE SCS LEAD SITE. REPORTEDL
EXTREMITIES. AN MRI WAS TAKEN AND A HEMATOMA WAS FOUND ABOVE THE LEAD. FOLLOW UP INFORMATION IDENTIFIED
THE DEVICE WAS EXPLANTED, BUT WAS NOT RETURNED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NONCON
IN HIS RIGHT LEG. THE DEVICE WAS EXPLANTED AND THE PATIENT HAS REGAINED MOVEMENT. THE PATIENT IS RECOVERING A
THE LEADS DURING IMPLANT.
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977D260, SERIAL (B)(4), P
FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIV
(B)(6) 2018. THE PATIENT HAD SHARP PAIN AND THEN NO FEELING IN THEIR LEGS. THE PATIENT WAS FLOWN TO THE HOSPITAL
TO THE LEGS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT I
THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL
SPINAL PAIN. THE REP REPORTED THAT APPROXIMATELY 5 HOURS AFTER LEAD IMPLANT, THE PATIENT BEGAN EXPERIENCING E
OPERATING ROOM IMMEDIATELY AND EXPLANTED THE WHOLE SYSTEM. IT WAS INDICATED THAT THERE WAS EPIDURAL HEMA
ANTICIPATED.
CORD STIMULATOR (SCS) ONLY LASTED A YEAR AND A HALF. THE PATIENT STATED IS MUST HAVE BEEN A "SHUSHU". THE PATIE
PATIENT STATED WHEN HER INS WENT OFF SHE JUST THOUGHT SHE WAS IN PAIN BECAUSE SHE DID NOT WANT TO GO TO A FU
WAS ABLE TO GET AN AGENT, AND GOT THE INS REPLACED. THE CALLER STATED THAT SHE WAS IN PAIN AND NEEDED HER WA
WAS PRIOR TO THE DEVICE. THE PATIENT STATED THE MANUFACTURING REPRESENTATIVE (REP) TOLD HER THAT THE DEVICE W
DEVICE. THE PATIENT THEN MENTIONED THAT A COUPLE OF HER FRIENDS TRIED TO GET THE DEVICE GET THE DEVICE BUT IT D
SYMPTOMS WERE REPORTED. EVENT DATE IS ONLY APPROXIMATE, MONTH AND YEAR ARE ONLY VALID. IF INFORMATION IS PR
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3777-75, SERIAL# (B)(4), I
3487A-45, LOT# V170864, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SU
NEUROSTIMULATOR (INS) FOR MULTIPLE BACK OPERATIONS. THE PATIENT REPORTED THAT SHE RECEIVED AN IMPLANT WHICH
REPROGRAMMING SESSIONS. THE PATIENT REPORTED THAT SHE CONSULTED WITH A DIFFERENT PHYSICIAN (HCP) WHO SUGG
REPORTED THAT SHE DIDN'T KNOW WHAT LEAD WAS LEFT. THE PATIENT REPORTED THAT THE HCP SAID THE LEAD WAS SO IMB
THAT THERE WAS A CONCERN THAT THE LEAD MIGHT HAVE MOVED. THE PATIENT REPORTED HAVING SACROILIAC JOINT PROB
REPORTED WEAKNESS THEN NUMBNESS AND PARALYSIS IN THE LEGS. NO FURTHER COMPLICATIONS WERE REPORTED.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HEADACHE, FACIAL NUMBNESS AND PARTIAL LEFT UPPER EX
WORK UP. THE PATIENT WAS REPORTEDLY DOING WELL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN TH
ATTACHED FOR YOUR CONVENIENCE IS THE FAX SENT TO YOU ON (B)(6) 2017. IF YOU WILL RECALL, YOU CALLED MY HUSBAND
BEEN IGNORED. I ALSO ATTACHED A COPY OF AN X-RAY SHOWING THE FRACTURED LEADS AND HARDWARE FAILURE, ALONG W
DEVICE BUT WAS DENIED. I DO HAVE THE REMOTE AND CHARGER FOR THE DEVICE ALONG WITH THE IDENTIFIERS ON THE WA
BEDRIDDEN AND CONFINED TO A WHEELCHAIR. ALTHOUGH DISABLED PRIOR TO THE IMPLANT, (B)(6) WAS ABLE TO PERFORM
CHANGED SINCE THE REMOVAL (3RD SURGERY). ON THE DAY FOLLOWING THE SURGERY, WE EXPECTED MINIMAL PAIN, AND E
POSTOP, HE COMPLAINED THAT HE COULD NOT MOVE HIS ARMS AND LEGS - HE COULD FEEL THEM BUT NOT MOVE THEM. TH
EXTREMELY WEAK AND UNABLE TO SUPPORT OR CARRY HIS OWN WEIGHT. THE BATTERY SITE AND HIS INCISION SITE BECAME
MENTALLY AND PHYSICALLY IT IS DESTROYING HIM. SINCE THE MALFUNCTION AND REMOVAL, HE HAS SUFFERED AND GONE T
BEGINNING TO SEE SKIN BREAK DOWN, EVEN THOUGH I TRY TO MOVE HIM AS MUCH AS POSSIBLE. THE DAMAGE DONE BY TH
NO END TO HIS SUFFERING AND PERMANENT DAMAGE. WE HAVE ABSORBED THE COST FOR SOME OF (B)(6) NEEDS. HOWEVE
BURDEN ON OUR FAMILY. (ALSO, WE ARE NOT FINANCIALLY ABLE TO CONTINUE TO DO SO) IN THAT REGARD, I HAVE ATTACHED
HUSBAND IS (B)(6) . HIS LIFE EXPECTANCY ACCORDING TO SC CODE SECTION (B)(4) IS 35.53 YEARS. PLEASE ADVISE ME WHAT W
AFTER COMPLAINING TO HIS PHYSICIAN THAT THE DEVICE WAS PAINFUL AND IT WAS ASCERTAINED THAT THERE WAS MALFUN
DETERMINED THAT HE NEEDED A REVISION. ON (B)(6) 2014, THE SURGEON REVISED THE STIMULATOR. THE BATTERY WAS REP
STIMULATOR SEEMED TO BE LIMITING HIS LEFT ARM EVEN MORE AND AFFECTING HIS ABILITY TO GRIP EVEN MORE THAN THE
FEELING PRIOR TO THE STIMULATOR IN ALL FINGERS AND NOW HAS ADVANCED TINGLING IN HIS LEFT THUMB POINTING FING
POKED BY THE LEADS, LEAVING MY HUSBAND TO LIE IN BED IN A SPECIFIC UNCOMFORTABLE POSITION CAUSING HIM MUCH D
DEBILITATING. WE WERE TOLD THAT MY HUSBAND WOULD EXPERIENCED A "WARMING FEELING", HOWEVER, INSTEAD, THE F
SCIENTIFIC CAN DO. SO WE BEGAN TO SEEK REMOVAL OF THE DEVICE. ON (B)(6) 2015, THE DEVICE WAS REMOVED. SINCE REM
RAISED WITH A VERY LARGE "LUMP." UNDERNEATH. I HAVE ATTACHED JUST A FEW OF THE HOSPITAL RECORDS. AS YOU CAN S
LUMBAR SPINE WERE DONE. THE RESULTS SHOWED MULTIPLE CHANGES TO INCLUDE STENOSIS, BULGING AND A TEAR IN DISC
APPOINTMENT WITH LEXINGTON BRAIN AND SPINE. FOR HIS CERVICAL SPINE-ON PAGE 4 IT SAYS THAT (B)(6) ISSUES ARE RELA
HOWEVER, BECAUSE OF HIS AGE, RECOMMENDATION OF DR AND THE RECOVERY TIME AND DOWN TIME THE FUSION ISN'T S
WHICH IS THE LAMINECTOMY AND THE DISCECTOMY. (B)(6) HAS BEEN BEDRIDDEN SINCE REMOVAL OF STIMULATOR. HE HAS
MINS, CANNOT BEAR WEIGHT ON HIS LEGS AND IS MOSTLY CONFINED TO THE BED. HE CAN NO LONGER TAKE CARE OF PERSO
BE APPRECIATED.
EXPERIENCING PAIN AND SHOCKING AT THE IMPLANTABLE NEUROSTIMULATOR SITE WHICH GOES DOWN THE RIGHT LEG AND
BEFORE, AND IT STARTED A COUPLE OF MONTHS PRIOR TO THE REPORT, CONFIRMED AS 2017. IN THE LAST FEW DAYS (CONFI
IF THE CHANGE IN THERAPY WAS RELATED TO POSITIONAL MOVEMENT. THEY WERE LOOKING TO BE REPROGRAMMED AS THE
SUPPLEMENTAL REPORT WILL BE ISSUED.
THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REPORT WAS RECEIVE
PARALYSIS. THE PHYSICIAN BELIEVED THAT THE CAUSE OF HEMATOMA WAS LIKELY EPIDURAL VEINS AND NOT PROCEDURE REL
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977C265, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE LEAD. IF
REPRESENTATIVE (REP) AND CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR
A RESULT OF POST-OPERATIVE COMPLICATIONS. PATIENT STATED THAT AFTER AWAKENING FROM SURGERY HE WAS IN TREME
PATIENT STATED THAT THE DEVICE WAS EXPLANTED-OFFICE HAS NOT CONFIRMED. NO FURTHER COMPLICATIONS WERE REPO
IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORAT
TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHY
PAIN OUTSIDE OF THE TARGETED PAIN AREA DURING THE TRIAL IMPLANT PROCEDURE, AND SHORTLY AFTER THE PATIENT REP
STIMULATION BEING DELIVERED IN THE TARGETED AREA. AS SUCH, THE TRIAL LEADS WERE EXPLANTED A DAY POST-IMPLANT.
TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHY
PAIN OUTSIDE OF THE TARGETED PAIN AREA DURING THE TRIAL IMPLANT PROCEDURE, AND SHORTLY AFTER THE PATIENT REP
STIMULATION BEING DELIVERED IN THE TARGETED AREA. AS SUCH, THE TRIAL LEADS WERE EXPLANTED A DAY POST-IMPLANT.
REPORTED THAT THE PATIENT'S STIMULATOR WAS CAUSING MORE PAIN. PATIENT REPORTED IT THROBBED REALLY BAD. PATIEN
WAS REPORTED DURING THE DAY IF PATIENT STOOD UP IT THROBBED ON INSIDE OF LEG. PATIENT REPORTED IT WAS REALLY B
FEELS LIKE IT IS BLACK AND BLUE BUT IS NOT. IT WAS JUST REALLY SORE. PATIENT REPORTED IT HURT AT THEIR LOWER BACK A
UP TO PUT IT INTO BED. IF PATIENT SAT CROSS LEGGED THEY WOULD NOT BE ABLE TO UNDO LEGS. LOCATION OF SYMPTOMS
DOCTOR A MONTH OR MAYBE A LITTLE LONGER AND THE DOCTOR STATED THERE WAS NO INFECTION. PATIENT STATED THEY
PARALYSIS. ADDITIONAL INFORMATION WAS RECEIVED. PATIENT REPORTED THAT INS WAS NOT WORKING AND THAT THEY HA
ISSUED.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURE REPRESENTATIVE REGARDING A PAT
EXPERIENCING BILATERAL LEG PARALYSIS FOLLOWING AN IMPLANT SURGERY. IT WAS NOTED THAT THE PATIENT VISITED THE E
EVACUATED AND THE INS SYSTEM WAS EXPLANTED. THE HCP ALSO PERFORMED A 4 LEVEL LAMINECTOMY(?). FOLLOW-UP WA
BECAUSE THE INS WAS DISPLACED. THE PATIENT STATED THEY HAD AN ARTIFICIAL DISC THAT FAILED AND BROKE DOWN IN TH
PATIENT SAID THEY DID SURGERY TO TAKE OUT THE DISC IN (B)(6) 2016, BUT THE PATIENT BECAME PARALYZED AGAIN AFTER
REMOVED THE STIMULATOR IN (B)(6) 2016. THE PARALYSIS STARTED PROBABLY IN EARLY (B)(6) 2016. NO FURTHER COMPLICA
EQUIPMENT OMITTED** EVENT DATE IS APPROXIMATE START DATE OF THE PARALYSIS. IF INFORMATION IS PROVIDED IN THE
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. INFORMATION WAS RECEIVED FRO
SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS PRESENTING NEW SYMPTOMS SINCE BEING IMPLANTED WITH SCS SY
WITH THE OTHER EVENTS, THE PATIENT REPORTED THAT HIS LEG JUST WENT OUT UNDER HIM. THE PATIENT HAS SURGICAL, T
HAVE A CT SCAN IN THE ER AFTER ONE OF HIS FALLS AND THIS WAS NEGATIVE. IT WAS REPORTED THAT THERE WAS A POSSIBI
THE STIMULATION TOO HIGH, SUCH THAT THIS COULD BE CAUSING THE PATIENT TO FALL. PATIENT ALSO HAS HAD SEVERE URI
2 DAYS AGO, IT WAS THE CLINIC'S WHEELCHAIR AND THE CALLER DID NOT THINK THE PATIENT TYPICALLY USED A WHEELCHAI
THERAPY/SYMPTOMS.
REGARDING MEDICAL HISTORY. IT WAS REPORTED THE PATIENT UNDERWENT A TRIAL IMPLANT PROCEDURE. PARALYSIS IN TH
PERFORMED AND NOTHING WAS FOUND. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT AND IS BEING TREATED FOR
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NE
WAS STATED ON THE RECHARGER THAT IT HAD TO BE PLUGGED IN AND DID NOT LEAVE THAT SCREEN. THE RECHARGER HAD B
CHARGER CONNECTOR PIN WAS FINE. PATIENT STATED THEIR INS WAS COMPLETELY OFF AND STIMULATION STOPPED THE DAY
MOVE, THEY HAVE SPASMS. IT WAS STATED WHEN SYSTEM WAS ON IT HELPS. PATIENT STATED THEY HAVE PROBLEMS WITH M
INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR COMPLEX REGULAR PA
APPROPRIATE INS/LEAD TO GO INTO THE PATIENT �S NECK. THE MALE/FEMALE PLUG WAS INCORRECT. THE REP DID HAVE A
BODY AND THE HCP COULD NOT FIT IT INTO THE PATIENT �S NECK SO THE IMPLANT WAS REMOVED AND NEVER PLACED. DU
CAUSING AN ENLARGEMENT) IN THEIR NECK AND PARALYSIS. THE PATIENT WAS INITIALLY DIAGNOSED AS A QUADRIPLEGIC B
THE INS WAS NOT THE PROPER SIZE FOR THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED. IF I
EVENT DATE IS APPROXIMATE. THE PATIENT SAID THE LOSS OF STIMULATION BEGAN A COUPLE OF MONTHS AGO. OTHER APPL
FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPO
THE LAST COUPLE MONTHS. THE PATIENT MET WITH A MANUFACTURER �S REPRESENTATIVE AT THE HCP OFFICE AND THE RE
ELECTRODES WERE FIRING AND THE REST WERE FIRING AT A REALLY HIGH LEVEL. THE PATIENT ASKED WHAT WOULD CAUSE TH
MENTIONED THE PATIENT�S LEAD WAS EMBEDDED IN THEIR SPINAL CORD AND THE HCP SAID THEY CAN �T REMOVE IT BEC
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977C165, SERIAL#: (B)(4),
IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS STILL IN THE
COMPLICATIONS WERE REPORTED.
INFORMATION WAS RECEIVED FROM A PATIENT VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO
REPORTED THAT THE PATIENT HAD POOR COUPLING WHEN RECHARGING. THEY STATED THAT THEY WOULD ON GET 0 TO 2 BA
PATIENT STATED THAT THEY WERE IN A WHEELCHAIR AND WAS LIFTED OUT OF THE CHAIR. AN ANTENNA LOCATE FEATURE WA
AND TOP NUMBERS, BUT THAT THEY WERE NEVER ABLE TO GET MORE THAN TWO COUPLING BARS. IT WAS REPORTED THAT T
RECHARGER, BUT THEY GOT THE SAME RESULTS. IT WAS REPORTED THAT POCKET ISSUES THAT COULD BE RELATED TO THE ISS
THAT THE EVENT OCCURRED IN (B)(6) 2017 AND NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION ALONG WITH X
COMPLICATIONS WERE REPORTED/ANTICIPATED. .
IT WAS REPORTED THE PATIENT IS EXPERIENCING PARALYSIS AFTER SHE UNDERWENT A LEAD IMPLANT ON (B)(6) 2017. THE PA
RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. (B)(4). ST. JUDE
THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
INFORMATION WAS RECEIVED FROM A MANUFACTURER �S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLAN
PATIENT WAS UNABLE TO RECHARGE THE BATTERY. THE REP REPORTED THAT THE PATIENT WAS PARAPLEGIC, WHEELCHAIR BO
REP REPORTED THAT THEY ATTEMPTED A SECOND RECHARGER, ATTEMPTED PATIENT LAYING ON THE CHARGER WITH NO SUC
REPLACEMENT. THE REP REPORTED THAT THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIO
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO T
OF 3. REFERENCE MFR. REPORT#: 1627487-2017-04921. REFERENCE MFR. REPORT#: 1627487-2017-04923. IT WAS REPORTED
SYSTEM WAS EXPLANTED. SURGICAL INTERVENTION ADDRESSED THE PATIENT'S ISSUE(S).
OF 3. REFERENCE MFR. REPORT#: 1627487-2017-04922. REFERENCE MFR. REPORT#: 1627487-2017-04923. IT WAS REPORTED
SYSTEM WAS EXPLANTED. SURGICAL INTERVENTION ADDRESSED THE PATIENT'S ISSUE(S).
DEVICE 3 OF 3. REFERENCE MFR. REPORT#: 1627487-2017-04921. REFERENCE MFR. REPORT#: 1627487-2017-04922. IT WAS R
PATIENT'S SCS SYSTEM WAS EXPLANTED. SURGICAL INTERVENTION ADDRESSED THE PATIENT'S ISSUE(S). SJM HAS LIMITED INF
THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WIT
PARTIAL PARALYSIS ON THE RIGHT SIDE. IT WAS STATED THE PATIENT HAD PRONGS FROM PAIN STIMULATION AND A GRANULO
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION
A REPORT WAS RECEIVED THAT THE PATIENT �S SKIN ABOVE THE ANCHOR REOPENED TO A 0.5 CM HOLE. THE LEAD WAS ALSO
SHOULD BE NOTED THAT THE PATIENT IS WHEELCHAIR BOUND. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLV
THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATIO
STERILIZATION RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SU
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEU
FOUR TO FIVE WEEKS AGO. THE PATIENT HAS BEEN IN PAIN SINCE THE FALL, AND THE PAIN WAS CONFIRMED TO BE THE TARGE
REPORTED. .
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1132, SERIAL #: (B)(4), DESCRIPT
MEDICAL FACILITY. A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PARALYSIS AFTER AN IMPLANT PROCEDUR
REASON FOR THE PATIENT�S SYMPTOMS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS STILL IN TH
A REPORT WAS RECEIVED THAT AFTER THE REVISION PROCEDURE THE PATIENT WAS EXPERIENCING NUMBNESS AND PARALYS
SYMPTOMS WERE NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION SUS
COVEREDGE 32, 70 CM 4X8 SURGICAL LEAD THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT TH
REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM T
RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MED
TAKEN AND CONFIRMED THAT THERE WAS NO HEMATOMA. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO HAVE TH
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMU
CONNECTOR PIN WAS BROKEN. THE PATIENT REPORTED THAT WHILE CHARGING THE INS THE CONNECTOR PIN WON �T STAY
THEY HAD A FALL AND BROKE THEIR LEG AND TIBIA AND FIBULA WHEN THEY WERE TRANSFERRING FROM A WHEELCHAIR. TH
REPLACEMENT RECHARGER. A REPLACEMENT INS RECHARGER WAS REQUESTED. A GOOD FAITH EFFORT WILL BE MADE TO OB
ISSUED.
I WAS SCHEDULED FOR A PERMANENT SPINAL CORD STIMULATOR IMPLANT WITH DR. (B)(6) WITH (B)(6) IN (B)(6), AT (B)(6). T
BELIEVE THE ANESTHETIST HAD LEFT THE SURGICAL SUITE FOR SOME REASON. THE DOCTOR KEPT YELLING AT ME TO STAY STI
WAS GIVEN MORE ANESTHESIA AND TAKEN TO RECOVERY. THE PAIN WAS UNBEARABLE. THE PERSON FROM BOSTON SCIENTIF
ABOUT THE PAIN, AND THAT I WAS HAVING DIFFICULTY STANDING AND WALKING. I WAS FINALLY SCHEDULED FOR A REVISION
STANDING AND WALKING, PARTIAL PARALYSIS, AND EXTREME PAIN. DOCTOR (B)(6) REFUSES TO REMOVE THE UNIT, AND TOLD
DECISION. IT HAS NOW BEEN ALMOST A YEAR, AND NOTHING HAS BEEN DONE, AND MY HEALTH HAS DECLINED TERRIBLY.
SURGICAL INTERVENTION WAS UNDERTAKEN AT AN UNKNOWN DATE WHEREIN THE SCS SYSTEM WAS EXPLANTED.
SWELLING AND WAS SITTING IN A WHEELCHAIR AFTER SURGERY. THE PATIENT REPORTED THAT PRIOR TO IMPLANT, SHE WAS
AFTER IMPLANT, SHE WAS GIVEN ZERO SETTINGS. A WEEK AFTER THE IMPLANT, THE PATIENT WAS GIVEN HIGH FREQUENCY SE
THERE WERE PROGRAMMING ISSUES. SHE HAS SINCE TURNED STIMULATION OFF, AND THE ABDOMINAL PAIN GOES AWAY WH
THE PATIENT TRIED TURNING IT ON AND TURNING IT UP, BUT THE ONLY PLACE SHE FEELS IT IN THE LEFT KNEE AND LEFT RIB. W
STIMULATION IN THE WRONG LOCATIONS. THE IMPLANTABLE NEUROSTIMULATOR IS NOT DOING WHAT IT IS SUPPOSED TO, T
HERNIATION AND SAID HER LOW BACK FEELS WORSE, BUT KNOWS THAT IT TAKES A LONG TIME FOR THE LOW BACK TO FEEL B
HER BELLYBUTTON AND RIGHT SIDE GOING AROUND HER LOWER RIBS ON THE RIGHT SIDE. THE PATIENT ALSO HAS DISCOMFO
PATIENT CHECKED THE DEVICE AT THE TIME OF THE REPORT, AND IT WAS ON A AT 6.3 VOLTS. THE PATIENT DID NOT HAVE ANY
REDIRECTED TO HER HEALTH CARE PROVIDER �TO WORK OUT PROGRAMMING AND PAIN ISSUES. � NO FURTHER COMPLICA
TO IMPLANT. THE PATIENT ALSO HAD AN L4 LAMINECTOMY PRIOR TO IMPLANT. A GOOD FAITH EFFORT WILL BE MADE TO OBT
ISSUED.
THE CONSUMER REPORTED THAT HER STIMULATOR WENT OUT ALMOST FOUR YEARS AGO AND SHE TRIED TO GET IT REMOVE
AGO AND HER DOCTOR STATED THE IMPLANT WAS MOVING AROUND IN HER BODY CLOSE TO THREE YEARS AGO. THE HEALTH
THE WIRES WERE TUGGING ON HER SPINE AND IT GOT TO THE POINT WHERE SHE NEEDS A WHEELCHAIR TO GET AROUND AS
A COUPLE OF FALLS LAST YEAR. THE INDICATION FOR USE WAS CHRONIC LOW BACK PAIN. A GOOD FAITH EFFORT WILL BE MAD
BE ISSUED.
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR
WAS STATED THAT THE PAIN HAPPENS MORE WHEN THE PATIENT CHANGES POSITIONS. IT WAS NOTED THAT ONE TIME THE PA
MOBILE AND HAD MORE PAIN AND USED A WHEELCHAIR. IT WAS NOTED THE PATIENT HAD LOST WEIGHT AND THE WEIGHT L
DAY OR TWO AND HAS LOST MUSCLE MASS AND BECOME FRAIL. LITERATURE AND TRAINING WAS REQUESTED FOR THE PATIE
EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFOR
. INFORMATION WAS RECEIVED FROM A CONSUMER ABOUT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR
DIFFERENT AREAS OF PAIN, WHICH THEY WANTED COVERED. IT WAS REPORTED THAT THIS WAS NOT A NEW PAIN, BUT THAT T
PATIENT STATED THAT THEY DID NOT KNOW HOW TO WORK THEIR PATIENT PROGRAMMER SO THEY HADN �T MADE ANY ADJ
WAS CURRENTLY ON GROUP B, P1 AT 510 V. THE PATIENT �S STIMULATION WAS TURNED ON AND IT WAS CONFIRMED THAT T
THEIR THIGHS. THE PATIENT STATED THAT THEY HAD A GROUP A AS WELL, BUT IT WAS INDICATED THAT THIS DIDN �T COVER
WAS GOING OUT. THE PATIENT CONFIRMED THAT THEY HAD NEVER HAD AN OVEREDISCHARGED DEVICE. THE LONGEVITY OF A
REDIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT BOTH THE DIFFERENT AREAS
REPORTED/ANTICIPATED.
INDICATED THE PRESENCE OF A HEMATOMA. SUBSEQUENTLY, THE HEMATOMA WAS REMOVED ON (B)(6) 2017.
A REPORT WAS RECEIVED THAT THE PATIENT STARTED TO DEVELOPED SYMPTOMS OF PARALYSIS SHORTLY AFTER THE IMPLAN
THE IMPLANT PROCEDURE, THE PATIENT REGAINED EIGHTY PERCENT (80%) OF PARALYSIS AND COULD NOW STAND. THE PHYS
FULLY RECOVERED BUT WAS A LITTLE WEAK. THE PHYSICIAN BELIEVED THAT IT WAS PROBABLY BE A POST-SURGICAL HEMATOM
EXPIRATION DATE: NI. A REPORT WAS RECEIVED VIA SOCIAL MEDIA THAT THE PATIENT EXPERIENCED PARALYSIS AND NERVE DA
WORSENED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8352-70 SERIAL#: (B)(4) DESCRIPT
LEFT LEG. IT WAS ALSO REPORTED THAT THE PAIN HAD CAUSED HIM TO COLLAPSE AND THE DEVICE HAD PUT HIM IN A WHEE
A REPORT WAS RECEIVED THAT THE PATIENT HAD A TEMPORARY PARALYSIS ON BOTH LEGS FOLLOWING A PERMANENT IMPLA
PROCEDURE. PHYSICAL THERAPY OR REHABILITATION WAS THE PATIENT'S MEDICAL TREATMENT. CONCOMITANT MEDICAL PRO
RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANA
FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
IT WAS REPORTED THE PATIENT SUFFERED LOWER LEFT LEG PARALYSIS DUE TO AN EPIDURAL HEMATOMA. THE PATIENT �S EN
TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. SJM HAS LIMITED INFORM
EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
IT WAS REPORTED THE PATIENT HAD CORD COMPRESSION WHICH CAUSED OCCASIONAL PARALYSIS IN THE LOWER EXTREMITI
THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING.
PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
IT WAS REPORTED THE PATIENT (AUSTRALIA) EXPERIENCED PARALYSIS AND WAS UNABLE TO MOVE HIS LEGS FOLLOWING AN S
PARALYZED. IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED V
2017 FROM THE CONSUMER REPORTING THAT THEY WERE SICK. INFORMATION INDICATED THAT THE PATIENT WAS WAITING F
BE NEEDED. THE PATIENT WAS IN A WHEELCHAIR AND IN A LOT OF PAIN. ADDITIONAL INFORMATION WAS RECEIVED FROM TH
LIKE THEY MAY PASS OUT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM THE CONSUMER REPORTING THA
HOT ON (B)(6) 2017. THE PATIENT STATED THAT THEIR LEFT LEG WAS AMPUTATED BELOW THE KNEE IN (B)(6)2016. WHEN THE
OF THE CALL THE PATIENT SWITCHED FROM PROGRAM A TO PROGRAM B. PROGRAM B FELT MORE COMFORTABLE BUT THEY W
PROGRAM B. THE PATIENT WAS FEELING STIMULATION IN THEIR LEFT LEG BUT NOT IN THEIR RIGHT LEG ON (B)(6) 2017. THE P
THIS ISSUE RESOLVED AND THE PATIENT WAS ABLE TO CONNECT THE PATIENT PROGRAMMER AND INCREASE STIMULATION. A
PATIENT WAS GETTING SHOCKED. THIS WAS A SUDDEN CHANGE. DURING THE CALL, THE PATIENT WAS HELPED TO CHANGE BA
REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF IN
IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A PERMANENT SCS SYSTEM ON (B)(6) 2017. WHILE IN POST OP, THE PA
OPERATING ROOM WHERE THE PATIENTS ENTIRE SCS SYSTEM WAS REMOVED. THE PATIENT HAS REGAINED MOVEMENT IN BO
VIA LABORATORY TESTING. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO
MEDICAL HISTORY.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL. IT WAS REPORTED THAT PATIENT'S WOUN
ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE EXCRUCIATING PAIN WAS PAIN CONTROL. THE CAUSE DETERMINED WAS PO
REPORTED/ANTICIPATED. INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING AN IMPLANTABLE NEUROSTIMULAT
AND HAD PUSS. THE PATIENT'S BATTERY THEN ERUPTED AND THE INS WAS REMOVED. THE PATIENT STATED THAT THEY CANNO
ON HOW MANY OF THESE DEVICES HAD THESE ISSUES. THE PATIENT WAS GIVEN THE DEVICE, AND THEY DON'T KNOW WHAT T
MALFUNCTION OR SOMETHING ELSE. THE PATIENT WAS CALLED BACK AND INFORMED THAT THE MANUFACTURER DOESN'T H
REPORTED OR ANTICIPATED. . A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO
A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT HAD DEVELOPED A HEMATOMA WHICH W
TO HAVE PRESSED DOWN IN THE CANAL CAUSING THE PRESSURE OR PARALYSIS. THE PATIENT UNDERWENT AN EXPLANT PROC
50 SERIAL #: (B)(4) DESCRIPTION: COVEREDGE 32, 50CM 4X8 SURGICAL LEAD THE EXPLANTED DEVICES WERE NOT RETURNED
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS AMBULATORY. DATE OF EVENT: (B)(6) 2017 ADDITIONAL S
A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT WAS HAVING ISSUES WITH HER LEGS AND
UNKNOWN WHAT CAUSED THE EVENT, HOWEVER, THE PATIENT WAS EXPERIENCING HIP PAIN WHICH SHE BELIEVED CAUSED H
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LOSS OF VISION AND LEG PARALYSIS. ADDITIONAL SUSPECT M
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT. IT WAS REPORTED THAT TH
WAS TAKING PAIN MEDICINE, BUT IT WASN�T HELPING. THE PATIENT WENT TO THE EMERGENCY ROOM FOR AN EVALUATION
OR EXTERNAL FACTORS WERE REPORTED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT �S HEALTHCARE
THAT THE PATIENT EXPERIENCED A POST-OPERATIVE EPIDURAL HEMATOMA, WHICH NECESSITATED EMERGENT LEAD REMOVA
REMOVED FROM THE EPIDURAL SPACE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED TEMPORARY PARALYSIS THAT THE
HOSPITAL AND WAS EXPECTED TO TRANSFER TO A LONG TERM REHABILITATION FACILITY. IT WAS UNKNOWN IF THE ISSUE WA
DISEASE, POST LUMBAR LAMINECTOMY SYNDROME, AND NON-MALIGNANT PAIN. CONCOMITANT MEDICAL PRODUCTS: PROD
OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEM
A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN EPIDURAL HEMATOMA. IT WAS NOTED THAT THE PATIENT H
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-8336-50, SERIAL #: (B)(4), DESCR
NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILUR
ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PARALYSIS IN HIS RIGHT AND LEFT LEG. IT WAS MENTIONED
THE PHYSICIAN DETERMINED THAT THE FEELING OF PAIN WAS IN THE MUSCLE AFTER A NON-DEVICE RELATED SURGERY.
DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2017-00598. IT WAS REPORTED THE PATIENT EXPERIENCED NUMBNESS AL
FURTHER INTERVENTION IS PLANNED TO ADDRESS THE ISSUE. (B)(4). IN THE EVENT THE DEVICE IS RETURNED TO THE MANUF
(B)(4). IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LA
HIS LEGS SHORTLY AFTER THE PERMANENT IMPLANT. THE PATIENT IS REPORTEDLY IN A WHEELCHAIR DUE TO BEING UNABLE T
A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING LOWER PARALYSIS FR
MALFUNCTION WAS SUSPECTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC
THE HEALTHCARE PROVIDER REPORTED ON BEHALF OF THE PATIENT THAT THEIR DEVICE DOES NOT WORK. THE PATIENT CLAIM
PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 FROM THE MANUFACTURER REP
(PRM) FOR THE PATIENT BUT BECAUSE THE CLINIC WAS CLOSING, THE PATIENT WENT HOME TO COMPLETE THE PRM ON THEI
PATIENT TO ADDRESS THE OVERDISCHARGE. THE REASON FOR NOT MAINTAINING RECHARGING WAS DUE TO UNRELATED MED
FEMUR DURING THAT TIME AND WASN'T ABLE TO CHARGE THEIR SYSTEM. IT WAS ALSO REPORTED THAT THEY HAD MULTIPLE
AFTER THE PATIENT RETURNED HOME AFTER THEIR HOSPITAL STAY RELATED TO THEIR FEMUR BREAK. THE PATIENT WANTED T
SYMPTOMS WERE REPORTED. RELEVANT MEDICAL HISTORY INCLUDES SPINAL PAIN. FOLLOW UP INFORMATION RECEIVED FRO
PATIENT WAS TO HAVE THE MRI AS SOON AS POSSIBLE SO THE INS WAS TO BE EXPLANTED. THE PATIENT WAS IMPLANTED FOR
A REPORT WAS RECEIVED THAT THE PATIENT REPORTED VIA SOCIAL MEDIA THAT SHE EXPERIENCED PARALYSIS, BURNING AND
UNDERWENT AN EXPLANT PROCEDURE HOWEVER THE LEAD WAS LEFT IMPLANTED. NO FURTHER INFORMATION CAN BE OBT
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977A260, SERIAL# (B)(4),
REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. A CONSUMER IMPLANTED
TOUCHING A NERVE DURING SURGERY. ACCORDING TO THE CONSUMER DURING SURGERY THE FIRST LEAD WENT IN FINE, BU
WOULD SCREAM IN PAIN. AS A RESULT THE CONSUMER SPENT A WEEK IN THE HOSPITAL AND HAD BEEN WALKING WITH A WA
SCHEDULED WITH THE HEALTHCARE PROVIDER (HCP) FOR (B)(6).
THE CONSUMER REPORTED THAT INITIALLY, THEY WERE UNABLE TO CHARGE THEIR DEVICE. IT WAS STATED, THEIR IMPLANTAB
COMMUNICATION ON THE PATIENT PROGRAMMER. THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE INSR. IT WAS RE
THE LAST SUCCESSFUL CHARGE SESSION WAS A WEEK AGO. THEY WERE IN PAIN AND COULDN'T WALK. IT WAS REPORTED THA
MEDICAL HISTORY INCLUDES SPINAL PAIN. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER A
PROGRAMMER, PATIENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE
IT WAS REPORTED THE PATIENT EXPERIENCED PARTIAL PARALYSIS AFTER THE PERMANENT IMPLANT PROCEDURE ON (B)(6) 20
SYMPTOMS PERSISTED POST-OPERATIVELY. ANOTHER LAMINECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2016 DURING W
PHYSICIAN, THE PATIENT DEVELOPED BROWN-SEQUARD SYNDROME OF UNEXPLAINED ORIGIN. AN MRI IS PLANNED AS THE N
TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDI
DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2017-00004.FOLLOW UP INFORMATION IDENTIFIED THE PATIENT HAS BE
ONGOING NEUROLOGICAL ISSUES AND USES A WHEELCHAIR. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S ME
PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MED
PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. (B)(4). DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2017-000004
TWO OCTRODES. THE TWO OCTRODES WERE IMPLANTED TO PROVIDE COVERAGE OF LEFT LEG PAIN.
(B)(4). DEVICE #2 OF 2: REFERENCE MFR. REPORT: 1627487-2017-000003. FOLLOW UP INFORMATION IDENTIFIED THE PATIEM
HAS ONGOING NEUROLOGICAL ISSUES AND USES A WHEELCHAIR. DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2017-0
IMPLANTATION OF TWO OCTRODES. THE TWO OCTRODES WERE IMPLANTED TO PROVIDE COVERAGE OF LEFT LEG PAIN. SJM H
PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
A REPORT WAS RECEIVED THAT THE PATIENT HAD PARALYSIS ON THE LEGS. THE PHYSICIAN DID NOT BELIEVE THAT THERE WAS
WAS DOING WELL POSTOPERATIVELY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#
INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAIN
INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
SECTION INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: P
LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2016 EXPLANTED: (B)(6) 2016 PRODUCT TYPE SCREENING DEVICE PRODUCT ID 977D26
IMPLANTED: (B)(6) 2016 EXPLANTED: (B)(6) 2016 PRODUCT TYPE SCREENING DEVICE. A GOOD FAITH EFFORT WILL BE MADE T
ISSUED. INFORMATION WAS RECEIVED FROM A REPRESENTATIVE (REP) REGARDING A TRIAL SPINAL CORD STIMULATION (SCS)
LAMINECTOMY WAS COMPLETED. THE SYSTEM WAS ALSO EXPLANTED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS R
DEVICE 1 OF 2. REFERENCE MFR.REPORT# 3006705815-2016-00725. FOLLOW-UP IDENTIFIED THE PATIENT REMAINS IN A SKILL
REPORTED POST SURGERY (REFERENCE MFR REPORT #3006705815 2016-00714) THE PATIENT WAS UNABLE TO MOVE HIS LEG
PERSISTED. A CT SCAN WAS ORDERED TO FURTHER ADDRESS THE ISSUE. FOLLOW-UP IDENTIFIED THE PATIENT WAS TRANSFER
HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE R
DEVICE 2 OF 2. REFERENCE MFR. REPORT#3006705815-2016-00724. FOLLOW-UP IDENTIFIED THE PATIENT REMAINS IN A SKILL
REPORTED POST SURGERY (REFERENCE MFR REPORT#3006705815 2016-00714) THE PATIENT WAS UNABLE TO MOVE HIS LEG
PERSISTED. A CT SCAN WAS ORDERED TO FURTHER ADDRESS THE ISSUE. FOLLOW-UP IDENTIFIED THE PATIENT WAS TRANSFER
CONCOMITANT MEDICAL PRODUCTS: MODEL#: SC-8336-50, SERIAL #: (B)(4), DESCRIPTION: COVEREDGE 32, 50 CM 4X8 SURGI
FOLLOWING AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PA
EVACUATION OF EPIDURAL HEMATOMA WITH PARTIAL LAMINECTOMY. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND
IT WAS REPORTED THE PATIENT WAS NOT RECEIVING STIMULATION DUE TO AUTO-REDUCING WITH IMPEDANCES READING HI
MAJOR COLLISION EVENTS, ONE BEING A CAR ACCIDENT AND ANOTHER WHEN THE PATIENT WAS STRUCK BY A CAR WHILE IN
THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING M
IT WAS REPORTED ON (B)(6) 2016, THE PATIENT UNDERWENT A PADDLE LEAD IMPLANT PROCEDURE. ONE LAMINECTOMY WA
ENTRY SITE. POST-OPERATIVELY, THE PATIENT EXPERIENCED PARALYSIS IN AN UNKNOWN LOCATION. THE PATIENT �S SYSTEM
BEEN DISCHARGED TO AN OUTPATIENT REHABILITATION FACILITY. (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PAT
DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. (B)(4).
(B)(4). IT WAS REPORTED THE PATIENT IS EXPERIENCING PARALYSIS FROM THE WAIST DOWN ON LEFT SIDE AND ALTERED SENS
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37083-40, SERIAL# (B)(4),IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTEN
(6) 2008, PRODUCT TYPE LEAD. A POSSIBLE PROBLEM WITH THE INS WAS REVIEWED / SUSPECTED / ALLEGED. REVIEWED MES
MONTHS. PT STATES THE PICTURE WOULD COME OFF AND ON BUT MANAGED TO "GET IT TO COME ON". PT STATES THE MESS
CONDITION WAS REPORTED: THE CALLER REPORTS A LOSS OF THERAPEUTIC EFFECT. ARE THERE SYMPTOMS: YES. THE FOLLOW
INS IS LOCATED, UP HER SPINE, THE MIDDLE OF HER BACK, SHOULDER BLADES, TAILBONE AND LEFT HIP. WHEN DID THE EVENT
HOSPITAL FOR A MAJOR MASS IN HER CHEEK. PT STATES SHE WENT TO THE ER ON (B)(6) 2013. PT STATES SHE WENT BACK TO
HOURS FOR THE MASS. PT STATES SHE HAS BEEN TAKING THIS FOR A DAY AND A HALF. PT STATES SHE TAKES A "LOAD OF OTHE
ALSO TAKING OXYCODONE AND SHE IS UNABLE TO DRIVE DUE TO THE MEDICATIONS SHE IS TAKING. PT STATES SHE HAS TO US
SHE SAW HER PAIN HCP JUST 1 WEEK AGO. PT STATES SHE DOES NOT HAVE ANY WAY OF GETTING TO THE HCP BECAUSE HER H
ABOUT THE FACT THAT IT HAS MOVED DOWN WITH WEIGHT LOSS. PT HAD APPT (B)(6) 2013 BUT CONCERNS WERE NOT ADDR
WAS REPORTED THAT THE HCP STATED THEY COULD NOT REPLACE THE BATTERY UNTIL (B)(6) 2013. THE CONSUMER REPORTE
NORMAL BATTERY DEPLETION. IT WAS REPORTED THAT SINCE THEIR ORIGINAL IMPLANT THEY HAD NOT BEEN ABLE TO LAY DO
TOOK SLEEP MEDICATIONS AND DID NOT FEEL PAIN. IT WAS INDICATED THROUGH THE REPORTED INFORMATION AND MANUF
RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITI
AGAIN. THE PATIENT STATED THAT THE ERROR CODE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT REPORTE
IT WAS REPORTED THE PATIENT DEVELOPED PARALYSIS 2 DAYS AFTER LEAD REPLACEMENT SURGERY. REPORTEDLY, SURGICAL I
CURRENTLY UNDERGOING REHABILITATION THERAPY. (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MED
PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
UDI = (B)(4). THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS IN
COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORM
EVENT: MODEL#: SC-8352-50, SERIAL #: (B)(4), DESCRIPTION: COVEREDGE X 32, 50 CM 4X8 SURGICAL LEAD. A REPORT WAS RE
THE PATIENT'S LOWER EXTREMITY WEAKNESS WAS PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDUR
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WIT
INJURIES FROM THE FALL. THE PATIENT WAS ACCIDENTALLY THROWN FROM THEIR WHEELCHAIR WHILE LEAVING HOME AND
WAS NOT WORKING AFTER THE FALL. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY AND WOULD BE GOING TO INPA
THE HOSPITAL TO A RECOVERY/REHAB CENTER. IT WAS REPORTED THAT NO ACTIONS OR INTERVENTIONS HAD BEEN TAKEN YE
INFORMATION WAS RECEIVED FROM A PATIENT WHO REPORTED THAT THEY FIRST NOTICED CHANGES IN THEIR STIMULATION
AND THE HCP INDICATED THAT NOTHING MOVED. REPROGRAMMING DIDN'T HELP AND PATIENT COULDN'T USE THEIR LEFT LE
EVEN THOUGH THEY TURNED THE STIMULATION OFF LAST NIGHT. INDICATION FOR USE IS SPINAL PAIN. A GOOD FAITH EFFOR
REPORT WILL BE ISSUED. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THAT CIRCUMST
THE STEPS TAKEN TO RESOLVE THE CHANGES IN STIMULATION, INABILITY TO WALK, AND FEELING STIMULATION WHEN IT WAS
WHETHER THE ISSUES RESOLVED, THE PATIENT REPORTED THE STIMULATION WAS OFF, BUT THEY WERE STILL HAVING PROBLE
WAS ALSO REPORTED THAT THE PATIENT HAD AN OUTPATIENT "ICC PAIN PROCEDURE" CONDUCTED ON (B)(6) 2016. THIS HAD
PATIENT WAS CONTINUING TO WORK WITH THEIR HEALTH CARE PROVIDER (HCP) REGARDING THE LEG ISSUE AND HAD AN AP
. INFORMATION RECEIVED FROM A PATIENT REPORTED THAT THEY HAD THREE SERIOUS FALLS AND LANDED ON THE LEFT SIDE
PATIENT HAD BEEN EXPERIENCING PARALYSIS AND SEVERE LIGHTNING BOLT PAIN GOING DOWN THEIR LEFT LEG, EVEN WHEN
FEEL THE LIGHTNING BOLT GOING DOWN THEIR LEFT LEG WITH ANY SLIGHT MOVEMENT. THE PATIENT STATED THAT THEIR HE
PLACE AND THAT THEY HAD A PINCHED NERVE THAT WAS CAUSING IT. THE PATIENT WAS ALSO TOLD THAT THEY COULDN'T FIN
THEY HAD THEIR INS REMOVED. IT WAS REPORTED THAT THERE WAS NO WAY TO FIND THE PINCHED NERVE AT THE ER FOR TH
�THREE PLUS EDEMA.� THE PATIENT VISITED A DIFFERENT HCP ON THE DAY PRIOR TO THE DATE OF THIS REPORT AND STAT
DAY, BUT MORPHINE WAS THE ONLY THING THAT WOULD CONTROL THE PAIN OF THE PINCHED NERVE AND IT WOULD ONLY L
TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITIONAL INFO
BACK PAIN. THE PATIENT HAD GONE TO THE EMERGENCY ROOM FOUR TIMES IN THE LAST FOUR DAYS. THE PATIENT HAD FALL
IMPLANT HAD TO BE REMOVED IMMEDIATELY AFTER SURGERY BECAUSE CERTAIN AREAS WERE NOT RESPONDING WHEN THE
THAT THE PATIENT REGAINED STRENGTH IN THE CORE AND LEGS, BUT WAS STILL NOT WALKING AS THEY DID BEFORE THE EVE
A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) REPORTED A LOSS OF THERAPY. THE PATIENT CANNOT FEEL STIM
HELPING THE PAIN IN MY BACK, IT WAS SEVERAL DAYS LATER" BUT WASN'T SURE IF THIS OCCURRED IN (B)(6) 2011. THE PATIEN
TELL WHERE THE PAIN WAS. THE PATIENT ALSO CLAIMED THE STIMULATION MADE HER FEEL VIBRATIONS THAT WERE "TOO HA
APPOINTMENT IT WASN'T CHARGED, AND SHE DIDN'T THINK IT EVER SUCCESSFULLY CHARGED. THE PATIENT SAYS HER HEALTH
"HER EQUIPMENT." PATIENT WAS IMPLANTED FOR RADICULAR PAIN SYNDROME. .
THE COMPANY REPRESENTATIVE (REP) REPORTED THE PATIENT EXPERIENCED LEG PARALYSIS TWO DAYS AFTER UNDERGOING
WAS NOT AVAILABLE. NO EXTERNAL FACTORS CONTRIBUTED TO THE EVENT. THE ACTION TAKEN TO RESOLVE THE ISSUE WAS A
REGARDING SEVERITY WAS CONSIDERED SEVERE. THERE WAS INJURY TO THE PATIENT. IT WAS NOTED THAT THE DEVICE DID N
SURGERY WAS PERFORMED, WHICH DID NOT RESOLVE THE PALSY. NO ADDITIONAL TREATMENT/INTERVENTIONS WERE SCHED
PHYSICIAN CONSIDERED ABOUT THE POSSIBILITY OF A HEMATOMA, DURING THE PROCEDURE. THE PATIENT NOTICED LEG PAR
INTERVENTIONS COULD NOT BE CONDUCTED PROMPTLY. THE INDICATION FOR USE INCLUDED LOW BACK PAIN DUE TO FAILED
AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977C190, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE
ON (B)(6) 2016, THE IMPEDANCE MEASUREMENTS WERE AS FOLLOWS: AT AN UNKNOWN AMPLITUDE, ELECTRODES 0-7 AND 9
WERE AS FOLLOWS: AT 0.25 VOLTS, 0.7 VOLTS, 1.5 VOLTS, AND 3.0 VOLTS, ELECTRODES 0-10 AND 12-15 WERE BETWEEN 450 O
AND 3902 OHMS AT 3.0 VOLTS. . INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A HEALTH CAR
IMPLANTED 2 WEEKS PRIOR TO THE REPORT. THE DAY PRIOR TO THE REPORT WAS THE FIRST TIME THAT THEY HAD TURNED T
TO THE REPORT AND ELECTRODE 11 READ HIGH. AFTER PERFORMING ABOUT 2 HOURS OF STIMULATION (USING THAT ELECTR
ARE SHOWING VALUES (IT WAS NOT SAYING GREATER THAN 20 ,000 OHMS AND GREATER THAN 40,000 OHMS). THE IMPEDAN
EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998, LOT# 0208404142,
REPRESENTATIVE THAT THE PATIENT EXPERIENCED PARALYSIS AFTER THE "RETURN IN CHAMBER." FURTHER CLARIFIED AS AFTE
PATIENT WENT BACK TO THEIR ROOM, AND THE PARALYSIS CAME. THE PATIENT HAD A DISCAL HERNIA AT D8 AND D9. THE CAU
IMPLANTED AND EXPLANTED ON (B)(6) 2016. THERE WAS NO PROBLEM WITH THE DEVICE. THE ISSUE WAS RESOLVED AT THE
THE CONSUMER REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT SINCE ABOUT ONE MONTH AFTER IMPLANT HE H
WOULD NO LONGER HELP WITH THE PAIN AND SOMETIMES MAKE IT WORSE WHEN IT WAS ON. THE PATIENT WAS SEEN ON (B
THAT ON (B)(6) 2016 HIS ELECTRIC WHEELCHAIR FLIPPED OVER ON HIM AND HE WAS ONLY GETTING ABOUT 5% RELIEF, BUT S
BECAUSE IT HURT TO TURN IT UP PAST .25MV ON ANY OF HIS GROUPS, BUT ON THE DAY OF THE REPORT IT WAS AT 1.5 AND H
REPORTED THAT THE PATIENT HAD TRIED TURNING THE DEVICE OFF AND STILL HAD THE PAIN. WHEN THE PATIENT WENT TO T
JUMP FROM ONE FOOT TO THE NEXT AND THE PATIENT DID NOT ALWAYS FEEL STIMULATION WHEN HE HAD THE STIMULATIO
MORE WHEN HE WENT TO LAY DOWN AND WHEN HE TRIES TO SIT BACK UP THE PAIN CONTINUED. THE PATIENT HAD AN X-RA
THE SAME ANGLE. IT WAS NOTED THAT THE PATIENT HAD SIMILAR ISSUES WITH HIS MEDICATIONS AND HAD COMPLEX REGIO
ISSUE COULD BE DISEASE RELATED AND THE PATIENT WAS GOING TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER. THE IN
INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS
2.9 THE SETTING WAS TOO LOW. THE PATIENT HAD TO SIT STRAIGHT AND SOMETIMES HAD TO TOGGLE THE STIMULATION ON
TRAUMA/FALLS WERE REPORTED THAT COULD HAVE BEEN RELATED TO THIS ISSUE. IT WAS ALSO NOTED THAT THE PATIENT W
REPRESENTATIVE (REP) ON THE MORNING OF (B)(6) 2016 PROVIDING SOME INFORMATION AND REQUESTING A CALL BACK TO
SETTINGS BEGAN ON (B)(6) 2016. THE PATIENT HAVING TO OGLE STIMULATION ON/OFF OCCURRED SINCE IMPLANT. ADDITION
THE PROBLEM IS THAT THE RIGHT LEG WAS THE SPECIFIC SIDE THAT HAD AN ISSUE. AT A LOW BUT MEDIUM RATE THE PATIENT
RIGHT SIDE SUPER SLOW AND INCREASED THE LEFT SIDE THE STIMULATOR SENSATION WOULD BLEND AND OPERATE CORREC
WAS IN THE AREA. THE PATIENT INCREASED THE LEFT SIDE AND THAT RAN GREAT AND WAS PRESENTLY THE WAY THE PATIENT
SIDE. THE ACTION TAKEN WAS TO BARELY RUN THE RIGHT SIDE AND SIGNIFICANTLY INCREASE THE LEFT WHICH SEEMED TO BL
JUMP IN THEIR LEG WAS A JOLTING AND WOULD ONLY OCCUR ON THEIR RIGHT SIDE WHEN TRYING TO INCREASE STIMULATIO
TRAUMAS, OR ACCIDENTS THAT COULD BE RELATED TO THIS EVENT. IT WAS NOTED THAT THE PATIENT WANTED THEIR DEVICE
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR RADICULOPATHY. IT W
THERAPY ISSUE. THIS WAS CONSIDERED A SUDDEN CHANGE IN THERAPY/SYMPTOMS THAT STARTED IN (B)(6) 2016. THE PATIE
THAN 50 FEET. THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED TO TREAT NEUROPATHIC PAIN IN HIS RIGHT LEG/FOOT
IMPLANTABLE NEUROSTIMULATOR BEING IMPLANTED WHICH INCLUDE: POOR BLOOD CIRCULATION IN THE LEGS AND NECRO
FEET. THE PATIENT HAS AN UNRELATED KNEE INFECTION AND HAS NEEDED TO REVISION OF HIS KNEE REPLACEMENT. THE PAT
WERE UNRELATED TO THE DEVICE OR THERAPY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMAT
INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS TRIALING A SPINAL
DURING THE STIMULATION TRIAL. THE MANUFACTURER REPRESENTATIVE WAITING FOR A LITTLE OVER AN HOUR PER THE IMP
PATIENT WENT TO THE EMERGENCY ROOM AND HAD HER SYSTEM REMOVED. SHE WAS NOT ABLE TO AMBULATE RELATED TO
OR CONTRIBUTED TO THE ISSUE. NO DIAGNOSTICS WERE PERFORMED RELATED TO THIS EVENT. THE CAUSE OF THE ACUTE LEF
PARALYSIS HAVE RESOLVED. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE CO
A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED WEAKNESS AND PARALYSIS IN HIS LOWER EXTREMITIES, AFTER HIS IM
UNDERWENT A LEAD EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. IT WAS ALSO NOTED THAT THE PHYS
WAS DOING WELL POSTOPERATIVELY. (B)(4). THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS THEY WERE DISCARDED BY
COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE
INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WH
EXPERIENCED SHARP SHOCKING SENSATION AROUND THE INS POCKET. IT WAS STATED THAT THE PATIENT HAD AN ACCIDENT T
CAR DOOR SECONDARY TO HER PARTIAL BILATERAL LOWER EXTREMITY PARALYSIS/WEAK LOWER EXTREMITIES. SHE FELT � PO
SOMEONE CAME TO HER AID AND HELPED "PRY" HER OUT OF HER CAR DOOR. THE PATIENT STATED THAT THE TIME OF THE AC
OR MOVEMENT. THE PATIENT STATED HER "SHOCKING" SENSATIONS DID NOT RESOLVE WITH TURNING THE INS OFF. SHE DID H
STIMULATION AND STOPPED RECHARGING. SHE APPARENTLY WAITED "TWO MONTHS" TO TALK TO HER PHYSICIAN ABOUT TH
EXPLANTED. THE PATIENT MENTIONED THAT SHE WAS GOING TO INFORM THE REP OF HER PROGRESS IN THE INTERIM IF HER
ONE COMPLETE LEAD AND BOTH ANCHORS FOR THE LEADS. THE SECOND LEAD WAS SCARRED INTO PLACE SO THE PHYSICIAN
PATIENT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY. CONCOMITANT MEDICAL PRODUCTS: PROD
IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_TLOCK_ANCHOR, PRODUCT TYPE
INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE
A REPORT WAS RECEIVED THAT AFTER THE TRIAL PROCEDURE THE PATIENT FELT BURNING SENSATION IN THE LEGS THEN WEN
RESONANCE IMAGING WAS TAKEN DUE TO SUSPECTED EPIDURAL HEMATOMA. AFTER A FEW DAYS OF NOT FEELING THE PATIE
(B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2316-50E, SERIAL #:(B)(4),
A CONSUMER IMPLANTED FOR NON-MALIGNANT PAIN REPORTED THEY "EPILEPTIC SYMPTOMS" ON (B)(6) OF 2016. THE CONS
DEVICE OR NOT. IT WAS NOTED THE PARALYSIS WAS TEMPORARY, BUT SINCE THEN THE CONSUMER HAD PARALYSIS IN THE MO
ON IT DID WORK AND TURN ON. THE CONSUMER CALLED THEIR HEALTHCARE PROVIDER'S OFFICE WHO TOLD THEM TO CONT
MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A
FOLLOW-UP IDENTIFIED THE PATIENT IS NO LONGER IN THE WHEELCHAIR. IT WAS REPORTED DURING TRIAL IMPLANT THE PHY
DISCONTINUED. IN TURN, THE PATIENT EXPERIENCED RIGHT LEG AND FOOT NUMBNESS. REPORTEDLY, THE PATIENT IS IN A WH
HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED.
INFORMATION RECEIVED FROM A CONSUMER REPORTED THAT A POOR COMMUNICATION SCREEN WAS SEEN ON THE PATIEN
NEUROSTIMULATOR RECHARGER (INSR). THE LAST SUCCESSFUL RECHARGE SESSION WAS REPORTED TO BE IN (B)(6) 2015 AND
THAT WAS UNRELATED TO THE IMPLANT. IT WAS REVIEWED THAT IF IT HAD BEEN GREATER THAN 3 MONTHS SINCE THE LAST R
RECEIVED ON (B)(6) 2016 FROM A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT STATED THAT THEY HAD AN MR
IMPLANTED ON (B)(6) 2014 AND IT WAS "NOT QUITE TO YEARS YET." IT WAS REVIEWED THAT THE ONLY WAY TO PROVE THAT T
OVERDISCHARGE STATE AND THEN PUT THE INS INTO MRI MODE. NO FURTHER INFORMATION WAS PROVIDED REGARDING TH
MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPL
WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE F
(B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-70, SERIAL # (B)(4),
LOT # 16611054, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. A REPORT WAS RECEIVED THAT THE PATIENT EXPERIE
THAT THE INCISION SITES WERE RAISED WITH A LARGE LUMP UNDERNEATH. THE PATIENT BELIEVED THAT THE SYMPTOMS WE
(B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION
WAS REPORTED THE PATIENT WAS EXPERIENCING A LOSS OF MOTOR AND SENSORY FUNCTION BELOW THE WAIST A DAY AFTE
REGAINED MOVEMENT IN EITHER LEG. THE PHYSICIAN ASSISTANT STATED THE PATIENT WAS ON "SPINE PROTOCOL" FOR PARA
A CONSUMER REPORTED THEY HAD INSTANCES WHERE THEY FELT AN INCREASE IN STIMULATION IN THEIR ARM THAT HAD CA
FURTHER REPORTED WHEN THE CONSUMER WAS NEAR A WHEELCHAIR AND SMARTPHONE THEY FELT A CURRENT IN THEIR L
THE SOURCES. THE CONSUMER INFORMED THE MANUFACTURER'S REPRESENTATIVE (REP) ABOUT THIS ISSUE WHO ADDED TH
WAS SCHEDULED FOR (B)(6) 2016. .
INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MAL
COLD COMPRESS OR SLOWED DOWN HER ACTIVITY THE BATTERY WOULD COOL DOWN. THE LOCATION OF THE SYMPTOMS W
THREE WEEKS PRIOR TO (B)(6) 2016. THE PATIENT HAS NOT HAD HER RECHARGER OR PATIENT PROGRAMMER SINCE (B)(6) 201
HEALTHCARE PROFESSIONAL STATED THAT THE PATIENT NEEDED TO TAKE MORE PRECAUTIONS WITH SAFETY AND THE PATIEN
NOTED THAT THE PATIENT FELT STIMULATION WHERE SHE NEEDED IT. THE PATIENT WAS TO CALL A HEALTHCARE PROFESSIONA
THE PATIENT REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED WORKING SOMETIME IN (B)(6) 2009 A
DOCTOR PERFORMED A DISCOGRAM AND DISCOVERED THAT THE PATIENT HAD 3 TORN DISKS. ONE WAS TORN OUTSIDE OF TH
OVERLAPPED THE DISCS AND THE PATIENT HAD NO CUSHION LEFT SO THE SURGERY SLOWLY BECAME INEFFECTIVE. IT WAS NO
THE DISK REPAIR SURGERY. THE PAIN IN THEIR BACK WAS NOT BEING MANAGED BY THEIR STIMULATION BECAUSE OF THE NEW
THE ISSUE WAS NOT DISCOVERED UNTIL AFTER THE INS WAS PLACED. THE THREE DISKS WERE BY THE PATIENT'S NECK AND FA
FUTURE TO ADDRESS THIS NEW PAIN. THE PATIENT WAS IMPLANTED FOR CHRONIC LOW BACK PAIN. .
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT
BUT THE PATIENT FELT THAT THE PAIN WAS CAUSED BY HOW THEY WERE MANIPULATED DURING THE SURGERY. THE PATIENT S
GOING THROUGH THIS SEVERE PAIN ISSUE. THE HEALTH CARE PROFESSIONAL (HCP) DID SEVERAL TESTS INCLUDING A CT SCAN
WHAT THEY RECOMMENDED BECAUSE THE PATIENT THOUGHT IT WAS TOO RISKY AND COULD HAVE CAUSED PARALYSIS. THE P
THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, PR
THE AWARE DATE HAS BEEN CORRECTED TO (B)(6) 2016. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTUR
NOT RECALL THE PATIENT SPECIFICALLY MENTIONING SHOCKING OR FALLING. THE MANUFACTURER REPRESENTATIVE HAD ME
NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT SHOCKING WAS OCCURRING INTERMITTENTLY AFTER SEVERAL
BECAUSE SHE FLIPPED BACKWARDS OUT OF HER WHEELCHAIR. THE FALLS HAD OCCURRED IN 2015 OR 2014. THE PATIENT HA
IMPLANTABLE NEUROSTIMULATOR. THERE WAS POOR TELEMETRY AND THE DEVICE WAS NOT OPERATIONAL. THIS WAS NOT A
WAS TOO STRONG. THE PATIENT TRIED TO LOWER THE SETTINGS BUT COULD NOT BECAUSE THE PROGRAMMER WOULD NOT
STIMULATION ON. THE ISSUES STARTED OCCURRING IN 2015. THE PATIENT SAW HER HEALTH CARE PROVIDER REGARDING THE
THE ISSUES HAD NOT BEEN RESOLVED AS OF (B)(6) 2016. THE PATIENT WAS IN PAIN.
A CONSUMER REPORTED THEY WERE SEEING THE POOR COMMUNICATION SCREEN ON THE PATIENT PROGRAMMER (PP), WE
UNABLE TO RECHARGE. IT WAS NOTED THE CONSUMER WAS CURRENTLY IN THE HOSPITAL BECAUSE THEY HAD A SEIZURE AND
NEUROSTIMULATOR (INS) WAS RECHARGED WAS THE END OF (B)(6) SO IT BECAME DISCHARGED, AND A REQUEST WAS MADE
BECAME PARALYZED ON THEIR LEFT SIDE, AND HAD BEEN IN REHABILITATION CENTERS WHICH IS WHY THEY DIDN'T CHARGE,
SIDE FOR A LONG TIME, WERE IN A WHEELCHAIR AND HOSPITAL BED, AND ALSO EXPERIENCED SORENESS AND AGITATION. TH
AND SHOWED THEM HOW TO CHARGE THE DEVICE. THE REP. WAS THEN ABLE TO START THE CHARGE ALLOWING THE DEVICE
THIS THERE WERE NO FURTHER ISSUES WITH THE DEVICE. RELEVANT MEDICAL HISTORY INCLUDES COMPLEX REGIONAL PAIN S
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. P
2015, PRODUCT TYPE: EXTENSION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVAN
A CLINICAL STUDY REPORTED THAT THE CLINICAL DIAGNOSIS WAS NEW ONSET OF THORACIC PAIN. THE PATIENT CONTINUED
PAIN. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. INTERVENTIONS INCLUDED REPROGRAMMING. THE ETIOLOGY WA
PROGRAMMING. RELEVANT MEDICAL HISTORY INCLUDED: NON-MALIGNANT PAIN, SPINAL STENOSIS
. THE PATIENT REPORTED THAT THEIR SPINAL CORD STIMULATOR (SCS) WAS "PUT IN LIKE 30 YEARS AGO, THE RECEIVER PART W
WIRE CONTACTS MUST HAVE COME LOOSE BECAUSE WHEN THEY PUT THE DONUT UP AGAINST IT THEY HAD TO PRESS IN DIFF
(REP) OUT THERE AND EXPLAIN TO THEM HOW THEY COULD FIX IT. THERE WERE NO REPORTS OF FALLS OR TRAUMAS BUT TH
ISSUE." THE PATIENT WAS RECOMMENDED TO CONSULT WITH THE HEALTH CARE PROFESSIONAL (HCP).
THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SPINAL CORD STIMULAT
PATIENT, THEY DEVELOPED AN INFECTION IN THE POCKET WHERE THEY PUT THE BATTERY AND IT OPENED UP. THEY WERE GO
LASTING ILL EFFECTS FROM THE INFECTION OR SURGERIES FOR IMPLANT/EXPLANT. THE SURGEON TOLD THE PATIENT THAT IT
PROVIDER (HCP) THAT (B)(6), ENTEROCOCCUS FAECALIS, AND DIPHTHEROIDS WAS DIAGNOSED ON (B)(6) 2010. SYMPTOMS OF
THE LEFT UPPER BUTTOCK/HIP AREA. THE LEFT UPPER BUTTOCK WOUND GOES BACK TO (B)(6) 2011 WHERE A NEW LEFT POST
THE WOUND OVER THE LEFT POSTEROLATERAL HIP BECAME INCREASINGLY REDDENED AND STARTED TO DRAIN. THE NEW WO
DID HEAL COMPLETELY. ON (B)(6) 2011, THE PATIENT NOTED INCREASED DISCOMFORT IN THE LEFT HIP WOUND AREA. IT WAS
LARGER. THE UNDERLYING DEVICE WAS NOW EXPOSED AND NO GROSS PURULENCE WAS NOTED. THE GRAM STAIN HAD NO N
PATIENT WAS HOSPITALIZED WHERE THE INFECTED STIMULATOR BATTERY AND 2 LEADS WERE EXPLANTED. THE PATIENT WAS
SURGICAL SITE HAD HEALED WELL AND THERE WAS NO EVIDENCE OF RESIDUAL INFECTION AT THE SITE. THERE WAS A REPOR
(6) 2011 WHERE ALL SITES WERE DECLARED HEALED. A HISTORY OF (B)(6) WAS REPORTED WAS TREATED AND RESOLVED BY TH
HYPOTHYROIDISM. THERE WAS A REPORT THAT THE PATIENT WAS WHEELCHAIR BOUND DUE TO LEFT LOWER EXTREMITY PAIN
CONTROL. THERE WERE NO SYMPTOMS OF UNCONTROLLED HYPERGLYCEMIA NOR SYMPTOMS OF UNTREATED HYPOTHYROID
DEVICE DUE TO WOUND DEHISCENCE AND EXPOSURE OF THE DEVICE. THE CULTURE OF THE OPEN WOUND/EXPOSED DEVICE
REPORTED THAT THE PATIENT DID HAVE EVIDENCE OF (B)(6) ABSCESS, IN THE LEFT LOWER LEG BUT NOT (B)(6), IN (B)(6) 2010.
DYSTROPHY, LEFT LOWER LEG. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANT SITE, WEAKNESS AND NUMBNESS OF
NERVE THAT SENDS PAIN DOWN THE LEFT LEG. THE PATIENT WAS EXPERIENCING MORE FREQUENT URINATION SINCE THE PAI
HELPED WALK WITH LESS PAIN. THE PHYSICIAN BELIEVED THAT THERE WAS NO PARALYSIS ASSOCIATED WITH THE PATIENT'S PA
INVOLVED IN THE EVENT: MODEL#: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.
(B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1132, SERIAL # (B)(4), DES
THAT THE PATIENT BEING WHEELCHAIR BOUND WAS DUE TO THE SCS IMPLANT. NO FURTHER INFORMATION CAN BE OBTAINE
NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT
WHEELCHAIR AND WAS UNABLE TO MOVE HER LEGS WELL. IT IS UNKNOWN IF THE SYMPTOMS ARE RELATED TO THE DEVICE O
. INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT P
WAS RELATED TO THE DEVICE OR THERAPY. THE PATIENT STATED THAT HE WANTED TO HAVE THE SPINAL CORD STIMULATOR R
PATIENT HAS NERVE DAMAGE TO THE SCIATIC NERVE IN HIS LEFT LEG, AND THAT IS THE ONLY THING THAT IT HELPED WITH, BU
HELPED FOR ABOUT A YEAR AFTER IMPLANT. THE PATIENT STATED NOT ONLY THAT, BUT IT MADE IT SO HE COULDN'T URINATE
STIMULATOR WAS IMPLANTED DESPITE KNOWING THAT. THE PATIENT IS CURRENTLY TAKING MORPHINE FOR HIS PAIN. THE PA
2016. THE PATIENT REPORTED THAT IF HE CANNOT HAVE AN MRI, HE WAS GOING TO HAVE A CT SCAN, BUT HE DIDN'T SEE HO
WOULD LIKE TO HAVE THE SYSTEM EXPLANTED; HOWEVER THERE IS NO PLANNED SURGERY FOR THE SYSTEM REMOVAL.
. INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATO
TISSUE AND HAD TO WORK AROUND THAT. IT WAS REPORTED THAT THE PATIENT WOKE UP WITH THEIR RIGHT LEG PARALYZE
REHABILITATION AND HAD GOT SOME MOVEMENT BACK. IT WAS MENTIONED THAT THEY ISSUE POSSIBLY COULD BE DUE TO S
CANE FOR SHORT DISTANCES AND A WHEEL CHAIR. FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER �S REP
FURTHER INFORMATION RECEIVED ON APRIL 5, 2016 REPORTED THAT THE REPRESENTATIVE WAS PRESENT AT THE SURGERY. N
PROCEDURE. IT WAS THEN NOTED THAT THE NURSE INFORMED THE REPRESENTATIVE THAT THE PATIENT FELT NUMBNESS IN T
PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT HAD A PRE-EXISTING CONDITION, TRANSVERSE MY
EXTREMITIES TO GO THROUGH DAY TO DAY ACTIVITIES, NOTING THAT THE PATIENT WAS VERY DEPENDENT ON THEIR UPPER B
SYSTEM WASN�T BENEFITTING THE PATIENT ANY MORE. THE PATIENT �S PARALYSIS/ LOWER EXTREMITY SITUATION HAS GO
REVISION, A FUSION. THE FUSION HARDWARE WAS NOT RELATED TO THE INS SYSTEM, BUT WAS RELATED TO THE FUSION. WH
PATIENT�S SPINAL CORD AND WAS �PRESSING DOWN� ON THE SPINAL CORD. THE PATIENT WAS SEEN TODAY, (B)(6) 2016
PADDLE COULD MIGRATE CONSIDERING THE AMOUNT OF TORQUE THE PATIENT HAD TO PUT ON THEIR BODY TO MOVE AROU
39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID 39565-30, SER
APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPO
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3887-33, LOT # V010928, I
7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANT
HISTORY OF CHRONIC LOW BACK PAIN AND POST LAMINECTOMY SYNDROME. THEY ALSO HAD A SIGNIFICANT HISTORY OF CER
EXTREMITY AND THE DEVICE HAD BEEN MALFUNCTIONING. THE CORD FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) W
DOWN SO THEY HAD TO REPLACE THE WHOLE DEVICE. A DOCTOR DID A SURGERY ON (B)(6) 2009 TO ATTEMPT TO REVISE THE
PASS THE REPLACEMENT LEAD BACK THROUGH A CICATRIX OF TISSUE AND HAD TO REMOVE THE ENTIRE SYSTEM. SINCE THIS
BACK. THERE WAS AN ONSET OF THORACIC-TYPE STABBING PAINS AND LOWER ABDOMINAL PAIN WHICH WRAPPED AROUND
WEAKNESS OF THE RIGHT LEG AND SEVERE PAIN IN THE LEFT LOWER EXTREMITY. THE PAIN WAS EXACERBATED BY AMBULATIO
AND THEY COULD NOT WALK. THE PAIN WAS INTRACTABLE SO THE PATIENT WAS REFERRED FOR HOSPITALIZATION, IMPATIENT
SIGNIFICANT HIP FLEXOR WEAKNESS AS WELL AS DISTAL RIGHT LOWER EXTREMITY WEAKNESS. THEY HAD LEFT HIP FLEXOR W
EXTENSOR HALLUCIS LONGUS, PERONEI, AND POSTERIOR TIBIAL WEAKNESS. THE GASTROCNEMIUS SOLEUS WEAKNESS WAS R
VIBRATION SENSE BILATERALLY. THERE WAS ALSO AN UNRESPONSIVE PLANTAR FLEXOR RESPONSE FORMING. IT WAS NOTED T
EPIGASTRIC PAIN AND NAUSEA BUT NO VOMITING AND MILD INTERMITTENT HEADACHES. THE PATIENT WAS ADMITTED TO TH
COMPREHENSIVE IMAGING WAS PERFORMED AND AN MRI OF THE THORACIC SPINE SHOWED SEVERE THORACIC STENOSIS AT
OF THE LIGAMENTUM FLAVUM UNDER THE T11 LEVEL CAUSING STENOSIS AND IMMEDIATE SUPERJACENT T2 SIGNAL CHANGE
ACROSS THESE LEVELS AND INVOLVING L5 AND SACRUM. THE CERVICAL SPINE CT SHOWED PRIOR CERVICAL ANTERIOR AND P
ADVISED A SURGICAL DECOMPRESSION TO THE PATIENT. LAMINECTOMIES WERE PERFORMED ON T11 AND THE CEPHALAD 1/3
LIGAMENTUM HYPERTROPHY CREATING A SEVERE STENOSIS AT THE T11 AND T12 INTERSPACE. THE LIGAMENTUM FLAVUM W
MICROSURGICAL TECHNIQUE. FORAMINOTOMIES WERE PERFORMED OVER THE T11 AND T12 NERVE ROOTS. THERE WERE AL
PULSATILITY OF THE DURAL TUBE. THE WOUND WAS IRRIGATED AND WAS CLOSED UP. THE PATIENT WAS TAKEN TO PACU IN ST
THE HEALTHCARE PROFESSIONAL REPORTED THE PATIENT REQUIRED AN MRI SCAN OF THE LUMBAR SPINE, WHICH WAS UNRE
OR THERAPY. THE PATIENT'S RECORD SHOWED THE PATIENT LOST ABILITY TO WALK - SECONDARY TO BILATERAL LEG PAIN WITH
BASICALLY WHEELCHAIR BOUND AND HAD BILATERAL LOWER EXTREMITY WEAKNESS AND MULTIPLE CHANGES OF THE LUMBA
UNKNOWN IF ANY ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE LOW BACK PAIN AND LOSS OF ABILITY TO WALK. A
EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED
PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT P
EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICL
REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNO
STIMULATORS. JOURNAL OF NEUROSURGERY. 2016:1-4. DOI: 10.3171/2015.8.JNS15396. SUMMARY: THIS STUDY INVOLVED RE
A THORACIC PADDLE SPINAL CORD STIMULATORS (SCSS) WITH RESPECT TO THE OCCURRENCE OF A SYMPTOMATIC EPIDURAL
THE SAME PERIOD OF TIME WAS DETERMINED. REPORTED EVENT: A (B)(6) FEMALE PATIENT WITH NO RISK FACTORS FOR BLEE
BECAUSE SHE WAS PARAPLEGIC AT 2 DAYS AFTER IMPLANT. THE PATIENT BEGAN EXPERIENCING SYMPTOMS 21 HOURS PRIOR
ANTIHYPERTENSIVE MEDICATIONS DUE TO NAUSEA. WHEN EXAMINED, SHE HAD NO MOVEMENT AND NO SENSATION IN HER
WITHOUT ANY RESIDUAL COMPRESSION. AT 5 MONTHS POSTOPERATIVELY, SHE HAD MINIMAL MOVEMENT IN HER LOWER EX
EVENT DATES, AND PATIENT OUTCOME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECE
ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAV
THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT W
DEVICE AND RE-INSTRUCT THE PATIENT TO MAKE SURE SHE KNEW HOW TO USE THE DEVICE. IT WAS NOTED THAT THE PATIEN
DISC DISEASE. IT WAS REPORTED THAT THE PATIENT HAD BACK PAIN. THERE WERE NO FALLS/TRAUMA REPORTED THAT COULD
VISITED THE DENTIST WHEN THIS STARTED HAPPENING. THE BACK PAIN WAS NOTED TO HAVE BEEN A SUDDEN CHANGE IN TH
HAD A SHOT ON (B)(6) 2016. THE PATIENT THEN WENT TO THE DENTIST ON (B)(6) 2016 AND DIDN'T HAVE HER STIMULATION O
WAS NOTED THAT THE PATIENT USED A HEATING PAD ON HER BACK ON THE LOW SETTING. THE PATIENT WAS TO FOLLOW-UP
NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUB
WAS FUNCTIONING WELL. THE PAIN HAD RESOLVED AND NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE PAIN. .
(B)(4). THE PATIENT REPORTED THAT 8 TO 9 MONTHS PRIOR TO THE REPORT THEY NOTICED THAT THEIR IMPLANTABLE NEURO
(6) THE PATIENT NOTICED BACK PAIN BEGINNING WHICH WORSENED AND THE PATIENT WAS NOW WALKING WITH A CANE, BE
PATIENT WAS GOING TO FOLLOW UP WITH THEIR DOCTOR TO ASSESS THE INS SITE AND EXAMINE THE PAIN. THE PATIENT WAS
STIFF AND A LITTLE PAIN RUN THROUGH. THE DOCTOR DECIDED TO GIVE THE PATIENT A SHOT IN THEIR BACK ON (B)(6) 2016.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGAR
HAD AN EPIDURAL HEMATOMA POST IMPLANT. THE HCP SAID SHE WENT BACK TO THE OPERATING ROOM TO EVACUATE THE
OF THIS REPORT. AT THE TIME OF THE REPORT, THE PATIENT WAS UNABLE TO MOVE HER LOWER EXTREMITIES. IT WAS NOTED
HEMATOMA WAS NOT DETERMINED, OTHER THAN OCCURRING POST OPERATIVELY. THE CAUSE OF THE LOWER EXTREMITY PA
WERE ALLEGED REGARDING THIS EVENT. (B)(4).
CONCOMITANT MEDICAL DEVICES: PRODUCT ID :NEU_INS_STIMULATOR, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTA
INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD AN IMPLANTABLE
THAT THEY WERE NOT PLACED CORRECTLY, AND THEY WERE "HITTING THE WRONG NERVE". THIS CAUSED PARALYSIS OF THEI
MONTH TO A MONTH AND A HALF. THE ISSUE WAS REPORTED AS COMPLETELY RESOLVED WITH NO SEQUELAE. THE INS REMA
CLOTTING) ARE RESOLVED. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED CHRONIC LOW BACK PAIN A
IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WIL
INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD AN IMPLANTABLE
THAT THEY WERE NOT PLACED CORRECTLY, AND THEY WERE HITTING THE WRONG NERVE. THIS CAUSED PARALYSIS OF THEIR
MONTH TO A MONTH AND A HALF. THE ISSUE WAS REPORTED AS COMPLETELY RESOLVED WITH NO SEQUELAE. THE INS REMA
CLOTTING) ARE RESOLVED. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED CHRONIC LOW BACK PAIN A
IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WIL
PRODUCT ID: NEU_INS_STIMULATOR, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT
(B)(4). CORRECTION: UPON FURTHER REVIEW, (B)(4) HAS BEEN REMOVED FROM THIS REPORT AT THIS TIME DUE TO THE PREV
THROUGH A MANUFACTURER REPRESENTATIVE THAT THE PATIENT �HAD HEMIPLEGIA IN POSTOP � AS OF FOUR DAYS PRIOR
HCP �THOUGHT THAT IT WAS LIKE A DYSTONIA. � THE HCP PERFORMED A LUMBAR PUNCTURE ON THE PATIENT AND NOTED
PERIOPERATIVE OR POSTOPERATIVE (POST-CRITICAL SYMPTOMS AFTER AN EPILEPSY). � WHILE THE PATIENT WAS �GOING BE
LATER REPORTED THAT THE WEEK PRIOR TO (B)(6) 2016 THE �PATIENT EXPERIENCED A FACIAL PARALYSIS. � IT WAS STATED T
(DUE TO A PERIOPERATIVE STIMULATION.� THE PATIENT �S SYSTEM REMAINED OFF AT THAT TIME. IT WAS NOTED THE PATIE
UPPER LIMB PAIN. IT WAS NOTED THERE WERE NO SURGICAL INTERVENTIONS PLANNED OR PERFORMED AND THE PATIENT W
ADDITIONAL INFORMATION IS RECEIVED. ADDITIONAL INFORMATION STATED THE PATIENT �S HCP �THOUGHT THAT THE PAT
DEVICES OR PROCEDURES. IT WAS NOTED �THE PATIENT WAS GETTING BETTER � AT THE TIME OF FOLLOW-UP. .
(B)(4). A CONSUMER REPORTED SHE HAD A CAR ACCIDENT AND NOW THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PRES
HER SKIN. THIS WAS NOTED AS A SUDDEN CHANGE IN THERAPY/SYMPTOMS. THE INS WAS LEANING BACK SOMETIMES, BUT N
AFTER EATING. THE CONSUMER HAD BEEN TO THE ER BECAUSE SHE ALSO HAD PARALYSIS. THE CONSUMER NOTED A MANUFA
APPOINTMENT TO MEET WITH A HEALTH CARE PROFESSIONAL AND STATED SHE WILL REQUEST TO HAVE THE IMPLANT REMO
ISSUE. INDICATION FOR USE INCLUDED SPINAL PAIN. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED
TIME, THE ISSUE WAS NOT RESOLVED. .
VOLUNTARY MED WATCH REPORT NUMBER MW5060047 WAS RECEIVED BY THE MANUFACTURER ON MAR 21, 2016. THERE W
SYSTEM. WITHIN A FEW HOURS AFTER IMPLANT THE PATIENT COULD NOT FEEL OR MOVE HIS LEGS. THE PATIENT WAS TAKEN
ABNORMAL RESPONSES. INTRA-OP FLUOROSCOPY SHOWED THE PENTA WAS MIDLINE AND STRAIGHT. FOLLOW UP INFORMAT
REHAB CENTER IN A WHEELCHAIR AND IS STILL HAVING ISSUES. THE PATIENT DID NOT NEED A WHEELCHAIR PRIOR TO THE IM
DURING SURGERY THEY MONITOR TO DETERMINE WHERE THE STIM IS HOWEVER THIS PATIENT WAS NOT SHOWING ANY RESP
TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIE
IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AROUND HER HIPS WITH STIMULATION TURNED OFF. IT WAS ALSO NO
THE PATIENT'S PAIN PATTERN IS RIGHT LOW BACK AND RIGHT LOWER EXTREMITY. SUBSEQUENTLY, THE PATIENT UNDERWENT
PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE
(B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2218-50, SERIAL #: (B)(4)
WERE COMPLETELY UNRELATED TO THE STIMULATOR. NO FURTHER COURSE OF ACTION IN RELATION TO THE STIMULATOR. A
WAS TURNED ON OR OFF. THE SHOCKING SENSATION WAS VERY SEVERE THAT WHEN THE PATIENT TURNED THE DEVICE OFF, H
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY REACHED E
TELEMETRY WAS RESTORED AFTER A FULL PHYSICIAN MODE RECHARGE. AFTER TELEMETRY WAS RESTORED AND A FULL NORM
IMPLANTED TOOK PLACE ON (B)(6) 2000 AND THE BATTERY WAS CHARGED TO 3.035 VOLTS. ON (B)(6) 2000 THE BATTERY HAD
RECEIVED FOR ANALYSIS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 201
ANALYSIS IS COMPLETED. THE CONSUMER REPORTED HER BACK WAS REALLY BAD BECAUSE SHE HAS BEEN UNABLE TO CHARG
AND SHE GOT THE POOR COMMUNICATION SCREEN ON THE PROGRAMMER WHEN SHE TRIED TO CONNECT TO THE INS. THE P
PATIENT STATED SHE DOES NOT WANT TO HAVE ANOTHER SURGERY. THE PATIENT STATED SHE KNOW SHE WAS IN THE OVERDI
CLINIC AND THE WHOLE CLINIC WAS CLOSED. SHE WENT HOME AND CALLED AND THEY TOLD HER THEY DID NOT HAVE HER O
OR THEY CAN PAGE THE REP FOR HER. THE PATIENT MENTIONED SHE HAS DIABETES, WHICH SHE HAD PRIOR TO IMPLANT. THE
BEEN USING THE DEVICE VERY MUCH PRIOR TO A FALL THAT OCCURRED IN (B)(6) 2015. THE PATIENT WAS SEEN ON (B)(6) 2015
PATIENT HOME TO COMPLETE THE CHARGING PROCESS. A POWER ON RESET (POR) WAS SEEN BUT NEVER CLEARED. THE PATIE
COMMUNICATE WITH THE INS BECAUSE THE BATTERY WAS DEAD. A PMR WAS DONE BUT IT SOUNDS LIKE THE POR STILL WAS
REP DIDN'T HAVE TIME TO DO A PMR AND PROPERLY DEAL WITH THE OVERDISCHARGE SITUATION. IT WAS REVIEWED THAT IT
OF OVERDISCHARGE, THE REP CAN PULL THE FILE TO SEE IF A THIRD STRIKE WAS TRIGGERED. THE REASON RECHARGING WAS
RECENT FALLS, WHICH WAS MAKING THE RECHARGING PROCESS CHALLENGING. THE REP COULD NOT TROUBLESHOOT DUE TO
REPORTED THE DEVICE WAS EXPLANTED ON (B)(6) 2015. AT THE TIME OF EXPLANT, THE BATTERY WAS OVERDISCHARGED. THE
RECHARGER BATTERY. THE PATIENT BECAME EXASPERATED AND STOPPED TRYING. SINCE THE BATTERY WAS OVERDISCHARGED
DEVICE. AT THE TIME OF THE REPORT, THE ISSUE WAS RESOLVED. MEDICAL HISTORY INCLUDES SPINAL PAIN.
. (B)(6). THE CONSUMER REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLACED ABOVE THE LEFT BUTTO
WAS THE BATTERY. THE PATIENT CONTINUED TO EXPERIENCE PAIN. TWO MONTHS PRIOR TO THE REPORT, THE PATIENT HAD E
SURGERY WAS SCHEDULED ON (B)(6) -2015 TO MOVE THE BATTERY BACK TO THE LEFT SIDE. THAT PATIENT WAS "THERE ALL DA
PATIENT FOR THE NURSE'S SAFETY." THE PATIENT WAS RELEASED ON THE SAME DAY. THE NEXT DAY, THE PATIENT HAD A 101 FE
EXCRUCIATING PAIN AT THE LEFT SIDE INCISION. THE BACK INCISION WAS FINE. THE PATIENT WENT TO THE ER AND "NOT EVEN
WAS GIVEN IV ANTIBIOTICS. BLOODWORK WAS PERFORMED. ON (B)(6) 2015, THE PATIENT WAS TOLD BY THE NEUROSURGEON
DISCOUNTED A SITE INFECTION. THE PATIENT THEN DROVE TO THE ER AND 2 DOCTORS TOLD THE PATIENT IT WAS INFECTED A
THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) FROM (B)(6) 2015 AND SHE WAS IN ISOLATION WITH (B)(6) AS WELL. TH
MIRACLE BUT THE PERMANENT ONE WAS NOTHING LIKE IT. IT WAS VERY HAD TO CHARGE, HARD TO REACH THE SITE TO TURN
PATIENT WAS TOLD THAT THE PHYSICIAN WOULDN'T REMOVE IT DUE TO HIGH RISK OF PARALYSIS. IF ADDITIONAL INFORMATI
(B)(4). THE CONSUMER VIA A HEALTHCARE PROVIDER REPORTED THAT THE PATIENT WAS GETTING A LUMBAR AND SHOULDER
NEUROSTIMULATOR (INS) HELPED BRIEFLY AND THEN PAIN RETURNED. THE PATIENT ALSO HAD WEAKNESS IN BOTH LEGS, WA
(B)(6) 2015 AND THE PROGRAMMER WAS SHOWING AN END OF SERVICE (EOS) MESSAGE. IT WAS NOTED THAT THIS EOS MESS
THERAPY. THE PATIENT WAS INDICATED FOR SPINAL PAIN. NO MRI RESULTS, CAUSE OF THE PAIN, INTERVENTIONS, OR OUTCO
RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
CONCOMITANT PRODUCT: PRODUCT ID 3776-75, SERIAL # (B)(4), PRODUCT TYPE LEAD. (B)(4). ADDITIONAL INFORMATION REC
CONSIDERING REVISION. AN X-RAY WAS DONE WITH NO LEAD MOVEMENT NOTED. ACTIONS/INTERVENTIONS NOTED AS PLA
FIXED DUE TO THE PROGRESSION OF HIS RSD, HE IS IN THE FINAL STAGES OF RSD. THE RESIDUAL EFFECT OF ANYTHING DONE
THE PATIENT ALSO CLARIFIED THAT WHEN HE INDICATED HE RECEIVED A REPLACEMENT "LEAD" HE WAS REFERRING TO THE R
GREAT FOR HIM. . ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. IT WAS REPORTED THAT THE MANAGIN
MANUFACTURER REPRESENTATIVE ON THE PHONE "TOOK CARE OF IT ALL". THE CIRCUMSTANCES THAT LED TO THE LEAD FAILU
QUICKLY. NOTE: IT APPEARED THE REPLACEMENT "ANTENNA LEAD" REFERENCED A REPLACEMENT ANTENNA THAT HAD BEEN
CLARIFICATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. THE C
PUT IN A NEW LEAD BECAUSE HIS REFLEX SYMPATHETIC DYSTROPHY (RSD) HAD ADVANCED SO FAR. THE PATIENT REPORTED T
HE HAS MUSCLE ISSUES AND IS ON THE EDGE OF STAGE 4 AND THE RSD HAS STARTED GOING INTO HIS BRAIN BECAUSE IT WAS
RELATED TO THE DEVICE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED FROM A HEALTH CARE PROFESSIONAL REPORTED THERE WAS NO PROBLEM WITH THE
ACTIONS/INTERVENTIONS NOTED AS PLAN ON REVISION IF NOT GETTING STIMULATION. FURTHER INFORMATION RECEIVED F
THE RESIDUAL EFFECT OF ANYTHING DONE TO HIM IS PAINFUL. HE WILL BE STARTING A NEW PROGRAM THAT WILL ASSESS HI
REPLACEMENT �LEAD� HE WAS REFERRING TO THE REPLACEMENT RECHARGER ANTENNA. HE ALSO RECEIVED A REPLACEM
THE CONSUMER. IT WAS REPORTED THAT THE MANAGING PHYSICIAN WAS NOT NOTIFIED ABOUT THE LEAD FAILURE. THE PAT
CIRCUMSTANCES THAT LED TO THE LEAD FAILURE INCLUDED "OLD AGE"/"6 YEARS". A NEW "LEAD" ("ANTENNA LEAD") WAS SE
REPLACEMENT ANTENNA THAT HAD BEEN SENT TO THE PATIENT. IT REMAINS UNCLEAR IF ANY STEPS WERE TAKEN TO RESOLV
FOLLOW-UP REPORT WILL BE SENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B
2015-00613 FOR THE OTHER LEAD. . THE CONSUMER REPORTED THAT THE LEAD THAT GOES INTO HIS NECK FAILED. THE PATIE
ADVANCED SO FAR. THE PATIENT REPORTED THAT HE HAD RSD SINCE 2005 AND IT WAS IN HIS ENTIRE BODY AND NOW HE WA
STARTED GOING INTO HIS BRAIN BECAUSE IT WAS AFFECTING HIS SPEECH AND MOTOR SKILLS. THE INDICATION FOR USE WAS
RECEIVED A FOLLOW-UP REPORT WILL BE SENT.
FOLLOW-UP IDENTIFIED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION IN ADDITION TO OVERSTIMULATION IN THE BA
OCCURRED RANDOMLY DURING AND PRIOR TO PROGRAMMING THE SCS SYSTEM. THE PATIENT ALSO STATED THAT OVERSTIM
INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY O
PATIENT EXPERIENCED BILATERAL LEG NUMBNESS AND HAD DIFFICULTY WALKING AFTER THE PERMANENT IMPLANT PROCEDU
PHYSICIAN, THE SYMPTOMS APPEARED TO BE UNRELATED TO THE SCS SYSTEM. AS OF 12/16/2015, THE PATIENT'S SYMPTOMS
HOWEVER, IT WAS REPORTEDLY IMPROVING. FURTHER INFORMATION WAS RECEIVED INDICATING SURGICAL INTERVENTION I
(B)(4). CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, LOT# 0206938300, PRODUCT TYPE: LEAD. (B)(4). ADDITIO
IMPROVEMENT OF PARESIS FROM 1 OUT OF 5 ON (B)(6) 2013 TO 2 OUT OF 5 ON (B)(6) 2013. REVALIDATION WAS DONE ON (B
STUDY REPORTED THAT THERE WAS PARESIS (RIGHT LOWER LIMB): SEQUELAE OF THE EPIDURAL HEMATOMA. NO DEVICE DEF
RESULTED IN PARESTHESIA AND PARESIS OF RIGHT LOW LIMB. THE ETIOLOGY WAS NOTED AS POSSIBLY RELATED TO THE DEVIC
(B)(4). CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37081-60, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4). REFER
PROFESSIONAL OF THE CLINICAL STUDY REPORTED THE PATIENT HAD MUSCLE WEAKNESS. THE PATIENT HAD IMPROVEMENT O
RESOLVED WITHOUT SEQUELAE IN (B)(6) 2014. THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPOR
WERE TAKEN AS AN INTERVENTION. DIAGNOSTIC METHODS INCLUDED A PHYSICAL/NEUROLOGICAL EXAM WHICH RESULTED I
PROCEDURE. THE ETIOLOGY WAS LEAD/EXTENSION TRACT. SIGNS AND SYMPTOMS INCLUDED PARESIS.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT �S HUSBAND THAT THE PATIENT HAD BEEN PARALYZED FROM
CATHETERIZATION OR FOLEY. SHE WAS MOVED TO A WHEEL CHAIR AND ABLE TO STAND WITH A WALKER. BACLOFEN WAS ADM
HOWEVER, AFTER TWO WEEKS, A RELAPSE OCCURRED. THREE MONTHS AFTER THE PROCEDURE, THE PATIENT IS STILL CONFIN
SENT TO A SPECIALIST DUE TO PLACING TOO MUCH STRESS ON THE PARALYZED, WEAK FOOT WHEN GETTING IN AND OUT OF
FOR RECOVERY RANGE FROM MODERATE TO NO IMPROVEMENT IN THE ABILITY TO WALK. A REPORT WAS RECEIVED THAT THE
CAREFUL TO TRY TO PLACE THE LEAD WITHOUT ADDING ANY EXTRA PRESSURE AND WHEN THE SYMPTOM HAPPENED, HE WA
PATIENT'S SCS WAS EXPLANTED TO RELIEVE THE PRESSURE WITHIN TWO HOURS, THE SAME DAY OF THE IMPLANT PROCEDUR
PATIENT WAS ABLE TO MOVE HER TOES AND ANKLES, BUT FROM THE HIP DOWN, SHE WAS UNABLE TO MOVE HER HIP OR KNE
WAS RECOVERING AND HAD YET REGAINED FULL FUNCTION OF THE LIMB. THE PARALYSIS WAS DUE TO THE LIMITED SPACE FO
TO BSN. (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT NO DEVICE MALFUNCTION WAS SUSPECTED.
(B)(4). THE CONSUMER REPORTED THAT HE ALMOST DIED AT IMPLANT FOR TWO REASONS. THE FIRST WAS THAT DURING THE
HEALTHCARE PROFESSIONAL (HCP) THAT PUT THE PADDLES IN HIS SPINE "SHOVED THEM IN, THEY WERE TOO BIG" AND HIS W
WORKED AND THAT WAS THE LAST THING HE REMEMBERED. THE PATIENT HAD TO BETAKEN BACK TO THE OPERATING ROOM
WALK NOW BUT WAS TOLD BY THE HCP THAT HE WOULD PROBABLY BE IN A WHEELCHAIR. THE PATIENT STATED THAT HIS LEGS
WERE FAILED BACK SURGERY SYNDROME AND LUMBAR RADICULOPATHY. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL
THE CONSUMER REPORTED POOR COMMUNICATION ON THE PATIENT PROGRAMMER. A POOR COMMUNICATION SCREEN AN
THE REPORTED ISSUE. IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT STIMULATION BASED ON POSTURE. THE PATI
WERE A CRIPPLE/IN A WHEELCHAIR, HAD 2 ARTIFICIAL SHOULDERS, AND CARPEL TUNNEL SYNDROME IN BOTH HANDS WHERE
OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. ADDITIONAL IN
REPORT WILL BE SENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMM
THE DEVICE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THERE WERE IMPEDANCE MEASUREMENTS. THEY WERE 0<
1<(>&<)>3 833 OHMS. THE REP STATED 1<(>&<)>C HAD A QUESTION MARK, BUT WHEN SHE RAN IT AT A LITTLE HIGHER VOLTA
OVERSTIMULATION ISSUE DOESN'T SEEM TO BE POSITIONAL EITHER, THE PATIENT IS IN A WHEELCHAIR, AND HE HAS LIMITED
HIGHER LEVEL. THE REP STATED AT 2.70 V, 330PW, 35 RATE, LONGEVITY IS 29 MONTHS FROM THE BEGINNING OF THE IMPLAN
LENGTH OF THE LEAD. THE REP STATED THE PATIENT EXPERIENCED INTERMITTENT STIMULATION SHUTTING OFF AND WHEN I
PATIENT'S FRIENDS WERE EVENTUALLY ABLE TO FIND A MAGNET TO TURN THERAPY OFF FOR HIM. THERAPY WAS PROGRAMM
PATIENT WAS IN TO GET INJECTIONS FOR HIS SHOULDER. IT WAS UNKNOWN IF THERE WAS ANY EMI. THE PATIENT HAS AN ELE
ISSUE. THE PATIENT WAS TO FOLLOW UP WITH THE HEALTH CARE PROVIDER (HCP). THE PATIENT STATED THERE WAS PAINFUL
IT'S BEEN ABOUT A YEAR SINCE THE ISSUE STARTED. MEDICAL HISTORY INCLUDES OTHER CHRONIC/INTRACT PAIN (TRUNK/LIM
REDUCE RISK. THE HCP HAS AGREED TO SCHEDULE HIM FOR A BATTERY REPLACEMENT PER PATIENT REQUEST DUE TO SHOCKI
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). INF
THEY BECAME WHEELCHAIR BOUND AFTER FALLING DOWN A FLIGHT OF STAIRS AND HAD NOT BEEN ABLE TO CHARGE OR USE
COULD HAVE AN MRI WITH THE INS IMPLANTED BUT THEY WERE NOT ABLE TO. IN ADDITION, THE PATIENT'S PROGRAMMER W
AS NON-MALIGNANT PAIN AND RADICULAR PAIN SYNDROME (RADICULOPATHIES). THERE WERE NO FURTHER DETAILS, INTERV
ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED.
THE CAUSE WAS NOT DETERMINED. THE PATIENT WAS CONSIDERING A REVISION. ADDITIONAL INFORMATION RECEIVED FROM
BEEN TAKEN TO RESOLVE THE ISSUE. THE PATIENT WAS TOLD THE WIRE THAT HELPED HIS LEGS WAS BROKEN. THE PATIENT CA
WALKS USE A CANE SOMETIMES. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
LEGS AND FOUND TO HAVE ELECTRODE IMPEDANCES OUT OF RANGE ON LEAD 8-15. THE PATIENT HAD AN APPOINTMENT ON
GOING TO THINK ABOUT REVISION. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE PATIENT WAS GOING TO
OTHER RELEVANT MEDICAL HISTORY INCLUDES SPINAL PAIN AND FAILED BACK SURGERY SYNDROME. NO INTERVENTIONS OR
INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. . CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37092,
ACCESSORY. PRODUCT ID: 355531, LOT# N308024, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID
TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEA
THE COMPLAINT OF EPIDURAL ABSCESS AND SEPTIC INFECTION CANNOT BE CONFIRMED VIA LABORATORY TESTING. (B)(4). SJ
PATIENT�S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT �S PHYSICIAN REGARDING MEDICAL HISTORY. U
PROCEDURE ON (B)(6) 2015 AND HAD THE IPG IMPLANTED ON (B)(6) 2015. FOLLOWING THE SECOND IMPLANT PROCEDURE, T
DAYS LATER, THE PATIENT BECAME UNCONSCIOUS AND IT WAS DETERMINED VIA FURTHER TESTING THAT THE PATIENT HAD A
COMA. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED. THE EXPLANT DATE IS UNKNOWN.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD; P
AN IMPLANTABLE NEUROSTIMULATOR (INS). THE INDICATION FOR USE INCLUDED SPINAL PAIN. THE CONSUMER REPORTED TH
WORKED SINCE. IT WAS REPORTED THAT THE PATIENT HAD THEIR TEST DEVICE FOR 4-5 DAYS AND ALL THEIR PAIN WENT AWAY
INDICATED THE PATIENT HAD A LOSS OF STIMULATION RELATIVE TO THE TRIAL, AND THE DEVICE WAS NOT HELPING. IT WAS R
CARE PROVIDER. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS ABLE
IMPLANT/EXPLANT ON (B)(6) 2015. THE PATIENT DID NOT KNOW IF THE DEVICE CAUSED THE PARALYSIS. THE INDICATION FOR
UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT.
REPRESENTATIVE (REP) REPORTED THAT THE PATIENT COULD NOT MOVE HER LEGS POST IMPLANT. THE NEUROSURGEON TEST
TO HAVE EVERYTHING EXPLANTED FROM THE PATIENT. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE R
OFFICE ON (B)(6) 2015. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-U
PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
A REPORT WAS RECEIVED THAT THE PATIENT HAD A HEMATOMA AND A MILD PARALYSIS OF THE LEFT LEG. THE PHYSICIAN BEL
PATIENT UNDERWENT A LEAD REMOVAL PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS RECOVE
COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8352-70, (B)(4), DESCRIPTION: COVEREDGE X 32, 70 CM 4X8 SURGICAL L
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS ACTING REALLY WEIRD 2 WEEKS AGO. INSTEAD OF ST
STIMULATION, BUT THEY WERE STILL GETTING STIMULATION. THE PATIENT SAW THE MANUFACTURING REPRESENTATIVE (REP
SOMETHING WAS WRONG WITH THE DEVICE AND TO CHECK IF THE LEADS HAD MIGRATED. IT WAS NOTED THAT 3 WEEKS AFT
WAS IN AREAS OF S1, S3, S4 AND S5. ALL WERE AFFECTED IN ONE OR ANOTHER. THE PATIENT WOULD GET STIMULATION BUT
AND STOMACH, AND IT FELT LIKE A BAND AROUND HER STOMACH. THE PATIENT HAD BEEN VERY UPSET AND HAD BEEN TO HE
SHE WAS NOT GETTING ANY RELIEF IN HER BACK AND WHY SHE WAS FEELING STIMULATION IN THE RIBS, ARM AND STOMACH
CONFIRMED THAT THE LEADS HAD NOT MIGRATED AND THAT THEY WERE IN THE RIGHT PLACE. THE PATIENT WAS 100% SURE
REPORTED SHE MET WITH THE MANUFACTURER'S REPRESENTATIVE (REP) 7 TIMES AND ON THE 7TH TIME SHE SUPPOSEDLY RE
THE PATIENT'S WAS CENTRAL LUMBAR IN S1 AND IT HAD BEEN GOING INTO THE HIPS AND INITIALLY PAIN IN THE HIPS AND ST
WAS CONTROVERSY BETWEEN IT BEING HER ARTERY DISEASE AND CRAMPING PAIN AND THIS ALSO OVERLAPPED WITH BACK
AWAY IN THE CALF AND NOW THE DOCTOR WAS GOING TO DO ANOTHER ONE IN THE FOLLOWING WEEK. IT WAS NOTED REGA
AND SOMETIMES ARM AND NOTHING IN THE LUMBAR AREA. THE REP TOLD THE PATIENT TO HAVE AN X-RAY. THE PATIENT ME
TWO PROGRAMS WERE PUT IN THAT DID NOTHING. IT WAS NOTED THE PATIENT DID NOT FEEL A SENSE OF SECURITY AND HA
GOING TO BE TAKEN CARE OF. THERE WAS STIMULATION WHEN IT WAS NOT SUPPOSED TO BE STIMULATING AND THIS STARTE
STIMULATION WAS THERE BUT IN THE LEGS AND IT WAS NOT SUPPOSED TO BE THERE. THE PATIENT DID NOT HAVE ALL THIS P
ONE WOULD TOUCH THE LEGS. THIS STARTED YEARS AGO AND THOUGHT IT WAS BACK ALL ALONG. 3 YEARS PRIOR TO THE RE
VASCULAR NEUROLOGY FOR 3 YEARS OF PATIENT HAD TO GO TO GRADUATION IN A WHEELCHAIR. THE PATIENT WAS SEEING A
AGAIN, BUT THE PATIENT HAD NOT GOTTEN A CALL. A FEW THINGS WERE BOTHERING THE PATIENT FOR THE PAMPHLET ON T
WEEKS PRIOR TO THE REPORT. A CARRYING CASE WAS GIVEN. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015
PROGRAMMER. PATIENT PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4). IT WAS
SIDE AND DOWN HER LEG. THE PATIENT SAID THAT THE STIMULATION WAS MORE LIKE SHOCKS. THE PATIENT FELT IT EVEN WH
THERAPY WAS OFF. THE MOST RECENT PROGRAMMING WAS A MONTH AGO WHEN THE REP MET WITH THE PATIENT TO TURN
ADAPTIVESTIM WAS NOT VERIFIED SINCE THE PATIENT WAS ALREADY COMPLAINING ABOUT THE STIMULATION NOT WORKING
WAS MORE OF A "VASCULAR" ISSUE PER HER HEALTHCARE PROVIDER (HCP), THUS SHE WILL NEED LEG SURGERY NEXT WEEK.
BACK. THE PATIENT DID GET IT AT ONE POINT BUT THROUGH THE PROCESS OF PROGRAMMING SHE HAD LOST IT. THE PATIENT
THAT SHE HAS GOTTEN STIMULATION IN HER STOMACH AS WELL. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGAR
UP REPORT WILL BE SENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REP WAS MADE AWARE OF THE ISSUE O
HOW IT WORKS AND WHICH GROUP WAS PROGRAMMED FOR HD. THE REP THEN WROTE DOWN THE GROUP THAT WAS IN HD
EXPLAINED TO HER ABOUT HOW THE HD WORKED AND THE PATIENT TURNED THE HD PROGRAM ALL THE WAY UP SO THAT SH
ADDITION THE PATIENT WAS GETTING STIMULATION IN THEIR STOMACH AND HAD NO STIMULATION IN THEIR LOWER BACK. T
PATIENT'S LOWER BACK WAS RESOLVED DURING REPROGRAMMING AND THE PATIENT WAS RE-EDUCATED ON HD AND TRADIT
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1132, SERIAL #: (B)(4), DESCRIP
WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COM
SUPPLEMENTAL MED WATCH WILL BE FILED. A REPORT WAS RECEIVED THAT IMMEDIATELY FOLLOWING THE IMPLANT PROCED
CONTUSION WHICH WAS THE CAUSE OF THE PARALYSIS. THE PATIENT'S SYSTEM WAS EXPLANTED. DEVICE MALFUNCTION WA
UNDERGO THERAPY.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# J0504281V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRO
PRODUCT TYPE: EXTENSION. (B)(4). THE MANUFACTURER REPRESENTATIVE REPORTED THAT IMPEDANCES WERE TESTED AT 5V
3379 26 ??? 27 2528 34 >4K 35 >4K 36 >4K 37 >4K 45 2017 46 3379 47 2528 56 2017 57 2017 67 2017. THERAPY IMPEDANCES
LOSING STIMULATION BUT NOT BEFORE. THERE WERE NO FALLS OR TRAUMA RELATED TO THIS ISSUE. THE MANUFACTURER R
AND THE PATIENT STILL COULD NOT FEEL STIMULATION. IT WAS NOTED THAT DOCTOR WOULD NOT REVISE THE SYSTEM AS TH
SITUATION. THE PATIENT'S VOLTAGE WAS HEALTHY AT 2.64V AND THE INS WAS SOMEWHERE BETWEEN 35-70% USED. THERE W
THE REP INDICATED THEY WERE ABLE TO USE TWO ELECTRODES AND PROGRAM AROUND IT OTHERWISE THERE WAS NO PLAN
INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS REPORTED BY THE PATIENT THAT AN "OUTPATIENT ADJUSTMENT" HAD NOT BEEN MADE SINCE (B)(6) 2014; THE PATIEN
PATIENT SUFFERED FROM THE CEREBRAL HEMORRHAGE, THERE WAS AN "EASING EFFECT" OF THE STIMULATION ON THE PAIN
PROCEDURE, AND THE PATIENT COULD NOT WORK OUT OR EXERCISE. IT WAS NOTED THE INS HAD BEEN CHARGED CONTINUO
LEVEL (OUTPUT). IT WAS CONVINCED THAT THIS MIGHT BE RESULTED FROM AN EFFECT OF THE CEREBRAL HEMORRHAGE. HO
THAN 40,000 OHMS DEPENDING ON THE PATIENT'S POSITION. THIS IMPLIED AN EFFECT OF A LEAD FRACTURE (OR A "TENDEN
ADVISED THE PHYSICIAN AVOID TURNING THE IMPULSES ON AT THE MAXIMUM OUTPUT. THE OUTPUT WAS CHANGED TO AN
SITUATION OF THE PATIENT. IT WAS NOTED BY THE ATTENDING PHYSICIAN THAT, JUDGING FROM THE SITUATION, THE TENDEN
REPRESENTATIVE REPORT THAT, ALTHOUGH THE LEAD FRACTURE OCCURRED IN 1 OF THE 2 LEADS, THE PATIENT HAD BEEN INF
ON THE OTHER HAND, NO "BIG TENSION" OCCURRED. THE PHYSICIAN WONDERED WHETHER A CONCLUSION COULD BE MAD
DEFECT WAS SUSPECTED AND THE PHYSICIAN REQUESTED THE SALES REPRESENTATIVE TO CHECK WHETHER OR NOT THE INS H
INFORMATION INDICATED THE CAUSE OF NO STIMULATION FELT AFTER THE CEREBRAL HEMORRHAGE WAS UNKNOWN. THE D
PROBLEM WITH THE LEAD OR EXTENSION, AND THAT THEY COULD TRY TO ISOLATE THE LOCATION OF A POTENTIAL BREAK WI
IN THE UPPER LIMBS THAT MADE IT NOT POSSIBLE TO DO HEAVY EXERCISES. THE HEALTH HAZARDS TO THE PATIENT WERE MI
977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: (
ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS NOT SURE ABOUT MEDICAL INTERVENTION PROVIDED TO THE PATIEN
THE EVENT: MODEL #: SC-1110, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). A REPORT W
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S SYMPTOMS OCCURRED IMMEDIATELY THE FOLLOWING DAY A
RIGHT ARM. NO FURTHER COURSE OF ACTION WILL BE TAKEN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLV
DESCRIPTION: LINEAR ST LEAD, 70CM. A REPORT WAS RECEIVED THAT THE NEWLY IMPLANTED PATIENT HAD PARALYSIS ON HIS
THE CONSUMER AND A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT'S DEVICE HAD POOR COUPLING WHE
RECHARGE. THEY WERE ONLY ABLE TO GET 4 COUPLING BARS AND WERE VERY FRUSTRATED. THE DOCTOR SUGGESTED THAT T
REPORTED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN T
MALIGNANT PAIN. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PROD
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT REGAINED FUNCTION OF HIS LEGS. THE PARALYSIS WAS A SURG
INVOLVED IN THE EVENT: MODEL #: SC-1132, SERIAL #: (B)(4), DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENER
FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA WITH SOME PARALYSIS. THE PATIE
PHYSICIAN ASSESSED THE EVENTS TO BE PROCEDURE RELATED AND NOT DEVICE RELATED.
THE PATIENT VIA A COMPANY REPRESENTATIVE REPORTED WHEN SHE WAS TRANSPORTED FROM BED POST-OP TO WHEELCHA
PATIENT WENT TO EMERGENCY ROOM (ER) AND THE DOCTOR IN THE ER THOUGHT IT WAS RELATED TO THE TRIAL SYSTEM. TH
THOUGHT IT WASN'T DEVICE RELATED. THE TRIAL SYSTEM WAS REMOVED ON (B)(6) 2015 AND THE PATIENT REPORTED THAT T
DAY PRIOR TO REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. CONCOMITANT MED
(B)(4). THE PATIENT REPORTED THAT THE PATIENT WAS PARALYZED AFTER IMPLANT WAS PLACED. THEY WERE PARALYZED WA
IMPLANT BECAUSE OF BEING PARALYZED. THEY WERE NOT PARALYZED AT THE TIME OF THE REPORT. THE PATIENT WANTED T
WILL BE SENT. ADDITIONAL RELEVANT MEDICAL HISTORY: FAILED BACK SURGERY SYNDROME SPINAL PAIN. ADDITIONAL INFOR
TOOK THE PATIENT BACK INTO SURGERY AND REMOVED THE IMPLANT. WHEN THE PATIENT WOKE UP THEY WERE TESTED FOR
STILL PERSISTED BUT TO A LESSER DEGREE. THEY ALSO WANTED TO KEEP THE PATIENT IN FOR OBSERVATION OR RETURN OF P
97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), PRODUCT TYPE: LEAD
(B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION
ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT'S PARALYSIS SYMPTOMS HAVE RESOLVED AND THE PATIENT HA
NUMBNESS. IT WAS ALSO REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH LEG PARALYSIS. AS A RESULT,
THE PATIENT WAS IN REHABILITATION.
(B)(4). THE PATIENT REPORTED THAT THEY WERE FEELING AND �ELECTROCUTION � SENSATION IN THE UPPER RIGHT QUADR
SHOCKING THE PATIENT STOPPED FEELING STIMULATION. THE PATIENT WAS IN A WHEELCHAIR AND FELL QUITE OFTEN BUT H
THEIR ARM. LATER THE SAME THE DAY THE PATIENT PRESENTED IN THE EMERGENCY ROOM. A MANUFACTURER REPRESENTAT
NO FURTHER TROUBLESHOOTING WAS PERFORMED. THE PATIENT ALSO NOTED THAT THEIR PATIENT PROGRAMMER WAS NOT
PRODUCT TYPE: LEAD. PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1991, PRODUCT TYPE: EXTENSION. PRODUCT
UPON FURTHER REVIEW, EVAL CODE-CONCLUSION DOES NOT APPLY. IT WAS REPORTED THAT THE PATIENT HAD EXTREME PAIN
EVENING THEY HAD SEVERE BACK PAIN AND COULD NOT GET COMFORTABLE. THEY WENT TO THEIR LOCAL ER AND LEADS WE
WAS NO SURGICAL INTERVENTIONS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SEN
SCREENING DEVICE. PRODUCT ID 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE:
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1132, SERIAL #: (B)(4), DESCRIPT
EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REPORT WAS RECEIVED T
PATIENT UNDERWENT AN EXPLANT PROCEDURE AND AN EPIDURAL HEMATOMA WAS EVACUATED. THE PARALYSIS WAS ASSES
DISORDERS WHERE SHE CLAIMS TO BE UNABLE TO MOVE HER LEGS.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT
IT WAS REPORTED THAT THE PATIENT �S DEVICE WAS CONFIRMED TO BE IN ITS FIRST OVERDISCHARGE. THERE WAS A COMM
NEUROSTIMULATOR (INS). THESE HEALTH ISSUES WERE NOT RELATED TO THE SPINAL CORD STIMULATION SYSTEM. THE PATI
BATTERY WAS RESET AFTER ONE PMR CYCLE AND THE BATTERY WAS CHARGED TO 25%. THE BATTERY WAS INTERROGATED AN
RESET (POR) WAS NOT ABLE TO BE CLEARED SO THE PATIENT WAS GOING TO FULLY CHARGE AND THEN HAVE THE POR CLEARE
OVERDISCHARGE AND SAW THE POWER ON RESET (POR). WHEN THE MANUFACTURER REPRESENTATIVE (REP) WENT TO CLEA
WAS DEAD AGAIN AND THE POR COULD NOT BE CLEARED. THE PATIENT WAS SENT HOME TO CHARGE THE INS. THE PATIENT W
THE INS AGAIN AND GOT IT TO 3/4, LOST COUPLING BARS AND THEN IT WENT BACK TO ZERO PERCENT. THE PATIENT WAS ABL
WHEN IN THE OFFICE WHEN THE PATIENT STOOD BUT THEY WOULD LOSE SOME WHEN THE PATIENT SAT IN THEIR WHEELCHA
TROUBLESHOOTING. THE INS WAS IN OVERDISCHARGE SINCE (B)(6) 2015. IT WAS INSTRUCTED TO HAVE THE PATIENT CHARGE
8 COUPLING BARS. WHEN THEY WENT TO GO CLEAR THE POR THE IMPLANT DEPLETED RIGHT BACK DOWN TO DISCHARGED ST
PULLED THE RECHARGE STATS. THE ERROR CODE WAS 0X3608. THEY RECEIVED THE POSSIBILITY OF SURGICAL INTERVENTION.
AFTER THE SURGERY, THE PATIENT REPORTED THE SURGERY "FAILED". IT LOOKED LIKE THE PATIENT NEEDED THE "E-WHEELCH
AND PAINFUL. (B)(4). IT WAS REPORTED THE PATIENT EXPERIENCED A �FRACTURED CABLE. � THE PATIENT WAS SCHEDULED
WAS UNKNOWN WHETHER THE PROCEDURE WOULD BE COMPLETED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONA
ADDITIONAL FOLLOW-UP INFORMATION REVEALED THE PATIENT REMAINS IN AN OUTPATIENT FACILITY, IS UNDERGOING PHYS
PATIENT HAS BEEN WHEELCHAIR BOUND BUT AS OF NOW HAS BEGUN WALKING WITH A WALKER. IT WAS ALSO REPORTED TH
REMOVED. IT WAS REPORTED THE PATIENT DID NOT RECEIVE EFFECTIVE STIMULATION COVERAGE FOR HER PAIN AND HER TH
SYSTEM WAS EXPLANTED WHICH RESOLVED THE REPORTED ISSUE. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT
THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDIC
PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. ADDITIONAL INFORMATION GATHERED REVEALED THE PATIENT UNDERW
ONE OR BOTH OF HER LEGS AND UNDERWENT REHABILITATION FOR TWO WEEKS. IN TURN, THE PATIENT IS WEARING A BRAC
OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIA
PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3777-60, SERIAL# (B)(4), IMP
PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). IT WAS REPORTED THAT THE PATIENT WAS HAVING TELEMETRY ISSUES WITH T
BATTERY AND COMPLAINED THAT THEY HAD NOTHING BUT PROBLEMS. IT WAS NOTED THAT THE PHYSICIAN HAD SWITCHED T
ISSUE; THEY SAT IN A WHEELCHAIR. WHEN THE MANUFACTURER REPRESENTATIVE (REP) MET WITH THE PATIENT, THE INS WAS
RECHARGER WAS PLACED ON THE PATIENT AND THE INS WAS ABLE TO BE CHARGED TO 25%. WHEN THE DEVICE HAD ENOUGH
ISSUES, HOWEVER, THE REP RESOLVED THE ISSUE AND THE PATIENT WAS NOTED TO BE RELIEVED AND HAPPY WHEN THEY WE
(B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT �S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINIO
HISTORY. IT WAS REPORTED THE PATIENT WENT INTO SURGERY TO ADD A LEAD TO THE EXISTING SYSTEM. DURING THE PROCE
CORD CAUSING TEMPORARY PARALYSIS. AS A RESULT, THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO THE POTENTIAL NEED
FOLLOW-UP REVEALED THE PATIENT WAS WALKING FINE.
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BATTERY DEPLETION THAT OCCURRED AFTER 4 YEA
INSURANCE COMPANY THAT THE MALFUNCTION OF THE DEVICE SHOULD BE COVERED BY THE MANUFACTURER. IT WAS NOTE
RECALL THIS WAS REFERRING TO. THE HEALTHCARE PROVIDER (HCP) GOT DENIAL FROM THE INSURANCE CLAIM FOR THE REPL
IN THE PAST, SINCE IMPLANT, BUT NOT NEAR THE TIME OF CHANGE IN RECHARGING FREQUENCY. THIS HAD OCCURRED IN (B)(
UNCOMFORTABLE FOR THE PATIENT TO CHARGE MORE OFTEN BECAUSE OF WEIGHT LOSS THAT HAD PROGRESSED FROM (B)(6
DUE TO CHARGING IN BED. THEY COULD CONSISTENTLY GET 6-8 COUPLING BOXES. THERE WAS A PATIENT INJURY. THE PATIEN
WAS INJURED BETWEEN THE WALL AND BED. THE PATIENT HAD CARPEL TUNNEL IN BOTH ARMS/HANDS FROM USING A CANE
COULDN�T WALK AND USE A WHEELCHAIR/SCOOTER. THE PATIENT HAD AN OVERALL DETERIORATION CONDITION, INCLUDIN
�HURT�. THE PATIENT HAD NUMEROUS OPERATIONS PRIOR TO THE IMPLANT, BUT ALSO AFTER, INCLUDING 2 ON THE BACK
PATIENT OUTCOME HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. C
TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUC
TYPE: ACCESSORY. (B)(4). . IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THERE WAS NO INFORMATI
INDICATED THAT THE BATTERY HAD BEEN OVERWORKED AND WAS NOT FUNCTIONING ANY LONGER. NO OUTCOME OR INTER
MANUFACTURING REPRESENTATIVE (REP) REPORTED THE HEALTHCARE PROFESSIONAL (HCP) SAID THAT THE PATIENT HAD TO
NOT APPROVE IT BECAUSE IT WAS A 9 YEAR BATTERY. THE INS WORKED. THE COVERAGE WAS SATISFACTORY AND THE PATIENT
WENT FROM CHARGING EVERY 2 DAYS TO 1 TIME PER DAY THEN TO 2 TIMES PER DAY ABOUT 5 MONTHS AGO. SURGICAL INTE
DONE. THEY WERE MADE AWARE OF THE SITUATION AND CALLED THE PATIENT TO GET CLARIFICATION. THE REP STATED TO CL
JUST DID NOT LIKE TO CHARGE AS OFTEN AS HE WAS HAVING TO. TH E REP ADDITIONALLY REPORTED THAT THE PATIENT DID N
BATTERY RECHARGE INTERVAL HOWEVER WORKERS COMP DID NOT APPROVE THIS. IF ADDITIONAL INFORMATION IS OBTAINE
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN ATTEMPTED LEAD REVISION PROCEDURE WHERE THE PHYSICIA
WEAKNESS AND PARALYSIS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN ORDER FOR THE PHYSICIAN TO PERFORM
FOLLOWING THE EXPLANT PROCEDURE AND WILL CONTINUE WITH REHABILITATION. DEVICE MALFUNCTION WAS NOT SUSPEC
THE EVENT WAS CAUSED BY THE PROCEDURE BUT CONFIRMED IT WAS NOT CAUSED BY THE DEVICE. ADDITIONAL SUSPECT M
MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). THE EXPLANTED DEV
FOLLOW UP INFORMATION REPORTED THAT THE PATIENT �S IMPLANTABLE NEUROSTIMULATOR (INS) REMAINED IMPLANTED
INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED. CONCOMITANT PRODUCTS: PRODUCT ID: 3708140, SER
LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 97740, SERIA
A FEW HOURS POST-OP. THE PATIENT HAD COMPLETE SENSATION IN THE LEG BUT COULD NOT MOVE IT. A CT SCAN WAS PERF
ABNORMAL SHOWED THERE. THE PATIENT HAD TO BE HOSPITALIZED DUE TO THE ISSUES. PARALYSIS OF THE RIGHT LEG WAS R
ANKLE, AND LIFT THEIR LEG SOMEWHAT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEI
IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED IN (B)(6) OR (B)(6) OF 201
RUNNING TESTS TO SEE HOW FAR THE DAMAGE IS. � THE PATIENT THEN REPORTED IN (B)(6) OF 2014 �I STARTED COMPLAIN
LAST YEAR IT STARTED WHERE IF I WOULD TURN IT UP IT WOULD HELP MY BACK BUT IT WOULD SEND JOLTS DOWN MY LEGS.
OF THIS YEAR THEY HAD TO DO EMERGENCY SURGERY TO TAKE IT OUT. IN (B)(6) OF 2014 THEY DID A CT SCAN AND IT SHOWED
OUT.� SINCE THE INS WAS TAKEN OUT THE PATIENT STATED SHE �HAD 52 FALLS SINCE THEN, AND MY LEGS LOG UP WHERE
CONDUCTION TEST TO SEE THE DAMAGE, AND I HAVE TONS OF HERNIATIONS FROM THE FALLS AND MY HANDS LOCK UP. � TH
IT STARTS WITH AN A, A PROBLEM THAT CAME FROM THE DEVICE BUT I DON �T KNOW WHAT IT �S CALLED BUT THERE ARE
DOCTOR THOUGHT THERE MIGHT BE SOME KIND OF RECALL ON THE STIMULATOR AND WANTED TO THE PATIENT TO CHECK IN
ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. CONCOMITANT MEDICAL PRODUCTS: PRODUC
3777-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6). PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: 2
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: PROGRAM
(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENS
SPINE. THE REASON FOR MRI WAS RELATED TO THE DEVICE THERAPY. THE DEVICE WAS CAUSING THE PATIENT NOT BE ABLE TO
PATIENT DID NOT HAVE A MANAGING DEVICE HCP. . IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT BEGAN HAVING TRO
STROKE, TUMOR OR THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD NOT USED THE DEVICE IN MORE THAN A
THE PATIENT HAD GONE IN FOR AN MRI SCAN AT A HOSPITAL AND AFTERWARDS HE COULD NO LONGER WALK AND SHAKING
WAS. A TECHNICIAN EVALUATED THE DEVICE AND SHE WAS UNSURE WHETHER IT WAS ON OR OFF. SHE ADVISED HAVING THE
WAS NOT DETERMINED BUT IT W AS DEVICE RELATED. THEY WERE UNABLE TO DETERMINE IF THE DEVICE WAS ACTUALLY FUN
NEUROLOGIST AND THEY WERE TOLD TO TURN STIMULATION OFF TO SEE IF THE INS WAS MALFUNCTIONING AND OR RULE O
PLACED A CUP ON HIS KNEE IT WOULD SHAKE AND FALL OFF. STIMULATION WAS TOO STRONG, HARD AND FAST AND THEY DID
THAT ONLY AFFECTED HIS ARM AND THEY PERFORMED TESTS TO RULE OUT STROKE AS BEING THE CAUSE OF HIS LEG ISSUES. T
THE MUSCLES WERE SO TIGHT AND TENSE HE COULD NOT WALK AND HE WAS IN A WHEELCHAIR. HE COULD NOT STAND UP S
�ROLLS LEFT� AWAY FROM HIS IMPLANT WHEN HE FELL. THE PAIN WAS SO BAD HE COULD NOT SLEEP OR EAT. THE PATIENT
STILL SHOWING GREEN INDICATING IT WAS ON. THE PATIENT REMOVED THE BATTERIES AND PRESSED EACH KEY IN THE CASE O
IMPLANT WERE FRIED� AND HE HEARD HIS DEVICE WAS RECALLED IN 2007. THE PATIENT WAS ADVISED TO COORDINATE WIT
(HCP) AND IT STILL WOULD NOT TURN THERAPY OFF. IF HE PLACED HIS HAND ON HIS KNEE OR ANKLE HE COULD FEEL THE BU
STIMULATION DOWN OR OFF AND THE HCP COULD NOT TURN IT OFF. THE HCP WAS GOING TO BE REMOVING THE INS NEXT W
OR USE THE RESTROOM. THE PATIENT HAD BEEN TO THE HOSPITAL TWICE BECAUSE OF THE PAIN STIMULATOR. HE HAD A CAT
RECEIVED WAS FOR A NEW UNIT WHICH WAS FOR 2007 AND THERE WAS A NEW UNIT WITH MORE BUTTONS. THE INS WAS �
AND BECAUSE HE WOULD FALL ON HIS FACE, HE WOULD HAVE TO GO TO THE HOSPITAL. IT WAS ALSO NOTED THAT THE HOSP
ALL, BUT THE PATIENT FELT LIKE THE INS WAS ON. THEY ALSO COULD NOT COMMUNICATE WITH THE INS USING THE PP, AND T
WHEN THE BATTERY WAS PLACED IN THE PP BUT THE 9V LIGHT WAS GREEN WHEN THEY PRESSED THE OFF BUTTON. THE PATI
THAN A YEAR AGO. THEY COULD NOT TURN OFF THE INS AS THE SUSPECTED IT WAS ALREADY DEAD.
1 OF 3. REFERENCE MFR REPORT#1627487-2015-08260, REFERENCE MFR REPORT#1627487-2015-08261. IT WAS REPORTED T
PERSISTENT LEG WEAKNESS AND PARESIS OF THE LOWER LIMBS. SUBSEQUENTLY, THE PATIENT WAS TRANSPORTED TO ANOTH
UNDERTAKEN ON (B)(6) 2015, EXPLANTING THE SCS SYSTEM AND EVACUATING THE HEMATOMAS. FOLLOW-UP INDICATED THE
PHYSICIAN PERFORMED AN ADDITIONAL SURGERY ON (B)(6) 2015 WHEREAS ANOTHER HEMATOMA WAS OBSERVED AND EVA
SENSATION. FURTHER FOLLOW-UP IDENTIFIED THE PATIENT WAS LATER TRANSFERRED TO A REHABILITATION FACILITY WITH N
UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO T
08261 FOLLOW-UP IDENTIFIED THE PATIENT WAS HOSPITALIZED WITH PNEUMONIA. REPORTEDLY, THERE HAS BEEN NO IMPRO
CARE.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN IN THE BACK AND PARALYSIS OF THE LEGS FOLL
HEMATOMA AND ADDITIONAL BONE WERE REMOVED. THE PATIENT REGAINED ALL MOVEMENT IN THE LEGS AND BACK PAIN
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REPORT WAS RECEIV
SAME DAY, IT HAD PROGRESSED TO LOSS OF FEELING BELOW THE WAIST. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS TAK
PARALYSIS OR WEAKNESS WAS A RISK OF ANY SPINE SURGERY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. MONITOR
PHYSICIAN REPORTED THAT THE DAY AFTER THE EXPLANT, THE PATIENT REGAINED ALL MOBILITY AND FEELING IN THE LEGS AN
IT WAS REPORTED THAT THE DAY AFTER THE PATIENT'S PERMANENT IMPLANT PROCEDURE, SHE DEVELOPED A SPINAL CORD I
WAS EXPLANTED. THE PATIENT HAS REGAINED SOME SENSATION IN HER FEET AND ANKLES BUT STILL DOES NOT HAVE MOTOR
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; P
PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL
REMOVED. AT THE TIME OF THE STIMULATOR REMOVAL, THE LEADS WERE COILED AND PLACED IN THE POCKET. THE PATIENT
PHYSICIAN WANTED TO CUT THE LEADS AT THE SKIN AND CONTINUE TO TREAT THE INFECTION. ADDITIONAL INFORMATION R
REPORTED BY AN MRI TECHNOLOGIST THAT THE PATIENT CLAIMED THE PHYSICIAN DID REMOVE PART OF THE LEADS. THE ENT
UNRELATED TO THE DEVICE, AND COMPATIBILITY GUIDELINES WERE GIVEN FOR A PARTIALLY IMPLANTED SYSTEM. IF ADDITION
ON (B)(6) 2014M, DR. (B)(6) WAS INSTALLING A SPINAL CORD STIMULATOR IN MY BACK. INITIALLY, I WAS LYING DOWN ON THE
LET HIM KNOW WHEN IT FELT COMFORTABLE. IMMEDIATELY I FELT A SENSATION THROUGHOUT MY WHOLE BODY FROM HEA
GOING TO TURN THE MACHINE DOWN AND THEN OFF. I LAID ON THE TABLE FOR A COUPLE OF MINUTES FEELING NOTHING A
PRESSURE ON MY LEFT LEG AT ALL. THEY PUT ME IN A WHEELCHAIR AND MOVED ME TO ANOTHER ROOM. THE TECH FROM B
THE MACHINE WAS TURNED ON, BUT IT WAS NOTHING LIKE WHAT HAD HAPPENED ON THE TABLE WHEN I WAS ZAPPED OUT
BACK PAIN THAN I EVER DID BEFORE THE PROCEDURE. I NOW HAVE TO WALK WITH A CANE AM TERRIBLE DEBILITATED.
IT WAS REPORTED THAT THE PATIENT �S SYSTEM WAS SCHEDULED TO BE EXPLANTED ON (B)(6) BECAUSE IT CAUSED PARALYS
POLICY WAS THAT IT WOULD GO TO PATHOLOGY FIRST BEFORE IT COULD BE RELEASED TO THE MANUFACTURING REPRESENTA
PROCEDURE AND THE USAGE OF THE STIMULATOR WAS NO LONGER A BENEFIT. NO OUTCOME WAS REPORTED REGARDING T
REPORT WILL BE SENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMM
2013-(B)(6),
THE PATIENTPRODUCT
WENT TO TYPE: LEAD. (B)(4).ROOM DUE TO LEFT HIP PAIN, RATED AT AN 8, AND THE SORE ON THEIR COCCYX. AN
THE EMERGENCY
SMALL AMOUNT OF DRIED BLOOD WAS NOTED ON THE DRESSING. THE PATIENT WAS AWARE TO CONTINUE WITH IV (PICC) AN
WOUND CARE NOTED IN (B)(6) OF 2015 THE PATIENT WAS SEEN IN THEIR HOME AND WAS ABLE TO DEMONSTRATE INDEPEND
PERFORM BASIC ACTIVITIES OF DAILY LIVING INDEPENDENTLY. THE PATIENT CONTINUED TO BE UNABLE TO GET UP FOR A LON
ABLE TO URINATE ON THEIR OWN, BUT WAS ENCOURAGED TO CONTINUE TO SELF-CATHETERIZE TO ENSURE THE BLADDER WA
MOTION/STRENGTH, BALANCE/GAIT, AND BEING AN INCREASED FALL RISK WITH SEVERAL FALLS NOTED. SYSTEM ASSESSMENT
JOINT STIFFNESS, POOR BALANCE, URGENCY, FREQUENCY, AND INCONTINENCE. IT WAS NOTED PREVIOUS URINE CULTURES A
INCLUDING ASSESSING, CLEANSING, PACKING, AND DRESSING CHANGES. DURING DRESSING CHANGES VARIOUS COLORS AND
ADDITIONAL INFORMATION RECEIVED FROM THE INFECTIOUS DISEASE PHYSICIAN STATED WHILE THE PATIENT WAS AT AN ACU
SACRAL DECUBITUS ULCER WHICH FAILED OUTPATIENT MANAGEMENT. FOLLOWING THIS ANTIBIOTICS WERE PRESCRIBED FOL
REPORTED WERE: HIGH RDW-CV, HIGH BUN, HIGH CO2, HIGH C REACTIVE PROTEIN, HEMOGLOBIN, HEMATOCRIT, RBC, SED. RA
BEING PARALYZED FROM T6 DOWN, DYSPHAGIA, A PRESSURE SORE ON THEIR COCCYX, PAIN, BEING DEPRESSED FROM HAVIN
QUICKLY FATIGUED WITH MOVEMENT, AND HAVING ARTHRITIS IN THEIR HANDS, BACK, AND NECK. AS OF (B)(6) 2015 THE PAT
TO HEAL DESPITE AGGRESSIVE WOUND THERAPY. ACCORDING TO THE PHYSICIAN THE WOUND HAD A PIN-AND HOLE APPEAR
TIP INSIDE OF THE WOUND AND WAS ONLY ABLE TO PROBE TO 0.3 CM. WITH A SMALLER SIZE Q-TIP. THERE WAS DISCUSSION
WORK ON STRENGTH AND MOBILITY, BUT CONTINUED TO BE FATIGUED AFTERWARDS. IT WAS NOTED THE PATIENT HAD ANOT
BELIEVED THEIR PROGRESSIVE LOSS OF TRUNCAL AND LOWER EXTREMITY SENSORY AND MOTOR FUNCTION, ALONG WITH W
SURGERY TO ARREST THE PROGRESSIVE LOSS OF FUNCTION AND ALLOW A CHANCE FOR FUNCTIONAL RETURN. THE PATIENT W
PATIENT WAS ALSO GOING TO BE HAVING SURGERY TO HER LEFT ULNAR NERVE FOR HAND WEAKNESS. IN (B)(6) OF 2015 THE
THICKNESS, STAGE 4, WITH A MODERATE AMOUNT OF DRAINAGE RANGING IN COLOR FROM BROWN AND YELLOW/SEROUS D
ON (B)(6) THE PATIENT UNDERWENT AN MRI OF THE SPINE WITH AND WITHOUT CONTRAST. RESULTS OF THE MRI SHOWED IN
SUSPECTED. THERE WAS WORSENED ENHANCEMENT AND EDEMA OF THE COCCYX ON THE PRIOR EXAM. THERE WAS NO DEF
BATTERY PACK IMPLANTED ON (B)(6) 2014, THE DOCTOR CONSULTED WITH A COMPANY REPRESENTATIVE . THE PATIENT HAD
ANOTHER POST-SURGICAL FOLLOW-UP ON (B)(6) 2014. AT THAT TIME THE PATIENT REPORTED THAT SHE FELL WHILE RIDING H
EXAMINING THE SITE IT WAS NOTED �SPOT DRAINING ON WOUND OPENING, CLEANSED BETADINE, CULTURE TAKEN, AND CL
WAS WOUND CHANGE DUE TO HER HISTORY. LATER THAT DAY THE WOUND CULTURE WAS EXAMINED AND DETERMINED THA
NUMBER OF ACINETOBACTER LWOFFI GROUP. THE PATIENT RETURNED TO HER DOCTOR ON (B)(6) 2014, AT THAT TIME SHE RE
GIVING OUT AND DUE TO LEG WEAKNESS, AND DUE TO HER LEG WEAKNESS SHE SUFFERED ANOTHER FALL. DURING THAT VIS
INFECTION AND WAS PROVIDED WITH ANTIBIOTICS THROUGH A PICC LINE. X-RAYS WERE ORDERED OF THE PATIENT �S SPINE
ASSESSED AS SUFFERING FROM A SPINAL CORD INJURY WITH NEUROLOGIC DEFICITS, SHE WAS AIRLIFTED TO A DIFFERENT ME
TRAVELED UP THE WIRE LEADS TO THE SPINAL CORD STIMULATOR AND THE SPINAL CORD ITSELF. FURTHER, AS A RESULT OF T
PARAPARESIS. LATER THAT DAY A NEUROSURGEON REMOVED THE SPINAL CORD STIMULATOR AND BATTERY PACK. A MULTILEV
THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO AN IN-PATIENT REHABILITATION HOSPITAL WHERE SHE SPENT SEVERAL M
TREATMENT. THE PATIENT ONLY REGAINED MINIMAL FEELING IN HER LEGS AND WAS CURRENTLY CONFINED TO A WHEELCHA
FOLLOW UP REPORT WILL BE SENT. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PR
INDICATING THAT THE PATIENT'S DEVICE HAD COMPLICATIONS. IT WAS NOTED THAT THE NEW BATTERY WAS INSTALLED ON (B
(B)(6) 2015, THE PATIENT WAS AIRLIFTED TO ANOTHER MEDICAL CENTER WHERE THE PHYSICIANS ALLEGEDLY DETERMINED TH
IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. (B)(4). CONCOMITANT MEDICAL PRODUCTS:
DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2015-12170. IT WAS REPORTED, THE PATIENT UNDERWENT AN SCS TRIAL
DURING THAT NIGHT THE PATIENT REPORTEDLY EXPERIENCED PAIN THAT WAS NOT RELIEVED BY THE STIMULATION AND THE P
FEET. THE PATIENT WENT TO THE ER AND IT WAS DETERMINED THERE WAS A SPINAL HEMATOMA. THE PATIENT'S LEAD WAS E
CURRENTLY ABLE TO FEEL HIS RIGHT FOOT AND IS BEGINNING TO MOVE HIS LEFT LEG. SJM HAS LIMITED INFORMATION RELAT
REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. THE PATIENT'S WIFE REPORTED THE PAT
WEEK. THE PATIENT IS WHEELCHAIR BOUND, HAS FEELING IN BOTH FEET BUT HAS NO FUNCTION IS HIS RIGHT LEG. THE PATIE
AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYS
THE PATIENT WAS IMPLANTED WITH TWO TRIAL LEADS HAVING THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT HAD
FRACTURED HIS LOWER LEG ON (B)(6) 2015. ADDITIONALLY, THE PATIENT EXPERIENCED FEVER, NAUSEA, VOMITING AND WEA
2015 AND WAS HOSPITALIZED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2015 FOR TREATMENT OF AN EPIDURA
IS UNABLE TO WALK OR BEAR WEIGHT ON HIS LEGS. PHYSICAL REHABILITATION WILL BE THE NEXT COURSE OF ACTION. THE PH
THE PATIENT'S PROGNOSIS IS UNDETERMINED BY THE PHYSICIAN AT THIS TIME. (B)(4). SJM HAS LIMITED INFORMATION RELAT
REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ABLE TO PLANTAR FLEX HER DIGITS ON HER RIGHT FOOT A
WAS RECEIVED THAT THE PATIENT WAS GETTING RIGHT LEG PARALYSIS DUE TO AN EPIDURAL HEMATOMA FOLLOWING THE IM
PERCEPTION IN HER RIGHT LEG BUT SHE STILL DOES NOT HAVE MOTOR MOVEMENT. THE EXPLANTED LEAD WAS NOT RETURN
CONCOMITANT PRODUCT: PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID
INFECTION IN THE WOUND/INCISION. THEY DID TWO ROUNDS OF STRONG ANTIBIOTICS WITH THREE DIFFERENT MEDICINES A
ON (B)(6) AND THE INFECTION STARTED THE WEEK AFTER IMPLANT SURGERY. THE PATIENT WENT TO THE HEALTH CARE PROV
STARTED VANCOMYCIN, LATER THAT WEEK SHE RAN OUT OF DOXYCYCLINE. IT WAS THE BEGINNING OF (B)(6) WHEN THE PATIE
THE PATIENT HAVING A PROBLEM WHILE ON VACATION, SO BEFORE LEAVING FOR VACATION LAST NIGHT THE HCP PERFORME
PEOPLE JUST GET INFECTIONS. IT WAS NOTED THE PATIENT HAS TWO DIFFERENT AUTOIMMUNE CONDITIONS AND THEY ARE
ONE INFECTION IN HER BODY THAT �FLARES UP � SHE IS SUSCEPTIBLE OF HAVING ANOTHER INFECTION, THEY THINK THAT I
HER A HUGE IMPROVEMENT OF HER QUALITY OF LIFE. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT THE O
TYPE: LEAD. (B)(4). THE END OF SERVICE/END OF LIFE (EOS/EOL) MESSAGE WAS REPORTED. THE PATIENT �CAN �T GET IT TO
THE PATIENT HAS BEEN HAVING PAIN FOR TWO DAYS. IT WAS STATED �ALSO A GUYS BACKED INTO ME IN A WHEELCHAIR ABO
INFORMATION HAS BEEN REQUESTED TO FIND OUT IF ANY INTERVENTION OR TROUBLESHOOTING WAS REQUIRED AND TO OB
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PTM
LEAD WAS USED. IT WAS UNKNOWN IF THE PARALYSIS WAS BECAUSE OF THE LEAD OR OTHER REASON. THIS OCCURRED �YEA
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708140, SERIAL# (B)(4) IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENS
2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRO
(B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4). (B)(4). FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL
PROGRESSING. THE PATIENT HAD A GOOD TRIAL NOT HELPING AFTER THE SURGERY. THE CAUSE OF THE ISSUE WAS NOT DETE
THEY HAVEN'T BEEN IN THE CLINIC SINCE (B)(6) 2015. AT THAT APPOINTMENT THE DOCTOR AGREED TO REMOVE THE DEVICE
SINCE THE (B)(6) 2015 APPOINTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. IT WA
PATIENT HAD NOT CHARGED OR USED IT IN 2 YEARS. THERAPY WAS NOT EFFECTIVE SINCE IMPLANT. THE PATIENT WAS ALSO F
WHEELCHAIR THERE WAS A LOT OF TWISTING HE WAS DOING WITH HIS BODY THAT COULD AFFECT HIS LEAD WIRES. THE PATI
REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORM
IT WAS REPORTED THE PATIENT STOPPED USING HIS SCS SYSTEM APPROXIMATELY FOUR YEARS AGO. THE PATIENT IS NOT SUR
UNCOMFORTABLE. THE PATIENT IS CONFINED TO A WHEELCHAIR AND WANTS HIS SCS SYSTEM TAKEN OUT TO ALLEVIATE HIS D
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA FOLLOWING A SPINAL CORD
SEVEN WEEKS AFTER THE EVENT WAS INITIALLY REPORTED, THE PATIENT HAD NOT RECOVERED; THE SYMPTOMS AND ISSUES W
WAS ON LOVENOX, AND STATED THAT HE HAD NOT HAD A DOSE FOR GREATER THAN 15 HOURS. IT WAS QUESTIONED IF THE P
MEDICAL PRODUCTS: PRODUCT ID: 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: SCREENING DEVICE. IT
ANTICOAGULANT, PLAVIX, PRIOR TO THE PROCEDURE AS ORDERED BY THE PHYSICIAN. FOLLOWING THE INSERTION OF THE TR
FROM THE WAIST DOWN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, PARALYSIS, AND WEAKNESS AT THE SPINE
WAS NOT REQUIRED DURING THE TRIAL. THE PATIENT WAS TO BE SEEN FOR POSSIBLE DECOMPRESSION SURGERY. IT WAS LAT
MALFUNCTION REPORTED. NO OUTCOME WAS REPORTED REGARDING THE RESULT OF SURGERY. ADDITIONAL INFORMATION
CONCOMITANT PRODUCTS: PRODUCT ID 3888-33, LOT # J0326942V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT
PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). IT WAS REPORTED THAT THE PATIENT HAD NOT USED STIMULATION FOR ABOU
INCREASE IT, AND FELT IT �THROUGH HER LEGS �, BUT WHEN SHE STOOD UP OR TOOK THE PATIENT PROGRAMMER AWAY F
USING THE PATIENT PROGRAMMER. THE PATIENT REPORTED �SEEING THE GREEN LIGHT FOR THE NEUROSTIMULATOR WAS N
HEALTHCARE PROFESSIONAL (HCP) BECAUSE HE WANTED HER TO TAKE OXYCONTIN. THE PATIENT WAS IN THE PROCESS OF GE
OR NOT. THE PATIENT STATED SHE WAS IN A ROLLATOR: A �WHEELCHAIR TYPE THING. � THE PATIENT NOTED ABOUT EIGHT M
DYSTROPHY (RSD). THE PATIENT WAS REDIRECTED TO THE HCP. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDIN
WILL BE SENT.
(B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2015 INDICATING THAT THERE WAS A LOSS OF THERAPEUTIC EFFE
WAS NOTED THAT IT WOULD NOT WORK. IT WAS NOTED THAT THE PATIENT MAY HAVE BEEN REPROGRAMMED BUT IT WAS U
ON AS OF (B)(6) 2015. IT WAS NOTED THAT THE UNIT MUST BE WORKING AS THEY WERE GETTING AN ELECTRICAL JOLT. THE P
LIKE A PATIENT PROGRAMMER SENT DIRECTLY TO THE PRISON. A TITANIUM PLATE WAS PUT IN BEFORE THEY HAD THE STIMUL
REPLACEMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. . CONCOMITANT MEDICAL P
PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT
THE DEVICE TO HELP THEM DEAL WITH THE EXCESSIVE PAIN AND DISCOMFORT CAUSED BY DAMAGE AND DETERIORATION OF
REGARDLESS OF THEIR TRAVELS OR ACTIVITIES. THIS WORKED WELL AS THE PATIENT MADE IT A NUMBER OF SETTINGS DAILY D
MALFUNCTIONING. THE PATIENT COULD NOT MAKE CONTACT WITH THE INTERNAL DEVICE WITH THEIR HAND HELD UNIT. MO
PAIN AND DISCOMFORT AT AN 8, ESPECIALLY THE LOWER LEVEL. MOST OF THE TIME THE PATIENT COULD NOT TELL IF THE DEV
EVEN THEIR FEET. THE TIME OF THIS WAS LIMITED. THE PATIENT MADE SEVERAL ATTEMPTS TO GET HELP FROM THE HCP. ON (
SERVICE, OR PLACE THE IMPLANT. THE PATIENT HAD BEEN GIVEN MEDICATIONS INSTEAD. TO DATE THE MEDICATION WAS OF
PATIENT WAS SCARRED THAT IF THE UNIT WAS NOT WORKING PROPERLY THE REASON MAY BE HARMFUL TO THE PATIENTS SY
WORKING MECHANICAL DEVICE. MUCH MORE IMPORTANTLY WAS THE PATIENT �S BEWILDERMENT. THE HCP IMPLANTED TH
AND DISCOMFORT. AT THE TIME OF THE REPORT, THE DEVICE WAS MALFUNCTIONING AND THE PAIN AND DISCOMFORT WAS
INFORMATION REGARDING CAUSE OF THE EVENT, INTERVENTIONS TAKEN, AND PATIENT OUTCOME HAS BEEN REQUESTED. IF
INTERROGATION ISSUES AND COUPLING ISSUES. IT WOULDN'T TO TELEMETRY WITH OR WITHOUT THE ANTENNA. THE ANTEN
STILL COULD NOT READ THE DEVICE. THEY CHANGED THE PROGRAMMER AND THEN THEY WERE SUCCESSFUL IN READING IT.
TESTING. THEY ALSO TRIED USING A DIFFERENT PROGRAMMER AND ANTENNA. IF THERE WAS A PRODUCT ISSUE THE ISSUE W
ASSOCIATED WITH THE EVENT. THE MANUFACTURER REPRESENTATIVE HAD THE PATIENT CONTACT THE HEALTHCARE PROVIDE
THE ANTENNA JACK WAS BROKEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE
THEY WERE STILL HAVE CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR REP
PLANTABLE NEUROSTIMULATOR (INS) MALFUNCTIONING FOR THE PAST 163 DAYS BEFORE THE UNIT WAS SERVICED WAS BECA
DAYS BUT THE PATIENT HAD NOT RECEIVED IT YET. THE REP. FURTHER NOTED THAT WHEN HE SAW THE PATIENT THERE WERE
ABLE TO TURN THE PATIENT'S DEVICE ON AND OFF. THE PATIENT WAS TO GET A NEW PP OR MAYBE SOME OTHER COMPONEN
THAT.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) WAS REMOVED ON (B)(6) 2014. THE PATIENT HAD AN ISSUE W
THAT THEY THOUGHT THE ISSUE WAS ASSOCIATED WITH IMPLANTING THE NEW LEADS ON (B)(6) 2013. THE HEALTH CARE PRO
HAD NOT USED THE SCS FOR A MONTH AND A HALF PRIOR TO REMOVAL. WHEN IT WAS TAKEN OUT, THE PATIENT DID GET TH
WAS GOING TO PHYSICAL THERAPY TO SEE IF SHE COULD GET HER LEGS MOVING AND WALKING AGAIN. IT WAS NOTED THAT
PATIENT STATUS WAS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (
PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODU
IT WAS REPORTED THE PATIENT PRESENTED TO THE HOSPITAL THE SAME EVENING FOLLOWING A PERMANENT IMPLANT DUE
WAS DISCOVERED DURING THE PROCEDURE. LEG MOVEMENT WAS RESTORED POSTOPERATIVELY THUS RESOLVING THE ISSUE
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 201
PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID
(B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AGO
NOTICED UNTIL SUNDAY. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND GIVEN KEFLEX. THE FOLLOWING SYMPTOMS
WAS THE DATE OF THIS REPORT. THE TYPE OF INFECTION WAS UNKNOWN. IT WAS UNKNOWN IF CULTURES WERE TAKEN. THE
REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITION
PARESIS AND HAD LOST 75 POUNDS OVER THE PAST SIX MONTHS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL
INFLAMED. IN ADDITION, ERYTHEMA WAS NOTED ALONG THE WIRE APPROXIMATELY 5CM. THE PATIENT NOTED THAT IT WAS
PRESCRIBED CEPHALEXIN FOR ONE WEEK. THERE WAS TO BE FOLLOW-UP IN THREE DAYS. NO OUTCOME WAS REPORTED REGA
REPORT WILL BE SENT. (B)(4) .
(B)(4). IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SHUT DOWN ON ITS OWN 2 TO 3 TIMES PER DAY.
SITUATION IN DIFFERENT POSITIONS TO NO AVAIL. AFTER THAT, IT WAS DIFFICULT TO SYNCHRONIZE OR SWITCH THE DEVICE O
SCREEN, SHOWING THE INS AND PROGRAMMER WITH A QUESTION MARK BETWEEN THEM, STATING THE PROGRAMMER COU
ADDITIONALLY, STIMULATION WAS IN THE RIGHT LOCATION AND THE LEAD WAS IN ITS "ORIGINAL PLACE". THE REPORTER STA
PROGRAMMERS FOR 17 YEARS AND USED IT WITH EASE. NO POWER ON RESET (POR) MESSAGES HAD BEEN OBSERVED WITH T
�DIFFERENT FROM NORMAL�. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF, AS WELL AS PROBLEMS SLEEPIN
STRIPS INDICATED UNIPOLAR IMPEDANCES WERE �AROUND 400-500 OHMS � AND BIPOLAR IMPEDANCES �AROUND 700-8
NOT PROPERLY INITIALIZED AND AS SUCH, PATIENT PROGRAMMER USAGE BY THE PATIENT COULD NOT BE DETERMINED. THER
HAD ALSO BEEN PERFORMED. THE WHOLE SYSTEM WAS GOING TO BE EXPLANTED BECAUSE THE SOURCE OF THE PROBLEM W
PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2
IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODU
(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4). . ADDITIONAL INFORMATION RECEIVED REPORTED THAT SHO
(B)(6) 2014. THE PATIENT DID HAVE A FALL THAT INITIALLY CAUSED THE SHOCKING AND JOLTING BUT THE SYMPTOM CONTINU
(INS), LEAD AND EXTENSIONS WERE REPLACED SHORTLY AFTERWARD. THE REPLACEMENT WAS INITIALLY SCHEDULED FOR (B)(
PRIOR TO REPLACEMENT. THERE WAS NO TROUBLESHOOTING PERFORMED DURING THE REVISION TO DETERMINE EXACT CAU
EFFECTIVE THERAPY WITH DESIRED COVERAGE AND NO SHOCKING SENSATION. IT WAS REPORTED THAT THE PATIENT EXPERIE
LIKE ROLLED DOWN THE STEPS". IT WAS CLARIFIED THAT THE PATIENT GETS A SHOCK WHEN THEY TURN THE WRONG WAY, AN
ALL OF THE WIRES BEING CONNECTED. THE PATIENT ALSO STATED THEY DID AN EXPERIMENT TO SEE IF RUNNING A HAIR DRYE
BECAUSE THEIR PAIN THEN RETURNS. USING THE INS, THE PATIENT WAS ABLE TO BE OUT OF A WHEELCHAIR AND WALK. THE E
WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
IT WAS REPORTED THAT THE PATIENT HAD SEVERE WEAKNESS IN THE LEFT LEG THAT STARTED 2 WEEKS AFTER IMPLANT. THE P
MANUFACTURER REPRESENTATIVE. THE WHEELCHAIR WAS STATED TO BE DUE TO THE EXTREME LEFT-SIDED WEAKNESS. FOLLO
FOLLOW-UP DETERMINED THAT NO NEW INFORMATION WAS KNOWN AS OF (B)(6) 2014. FURTHER FOLLOW-UP WAS PERFORM
RESULTS OF THE MRI WERE, AND IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THIS EVENT WILL BE UPDATED IF ADDIT
TYPE: LEAD. PRODUCT ID: 977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURING REPRESENTATIVE SAW THE PATIENT ON (B)(6) 2
AND RECHARGE THE DEVICE. (B)(4). IT WAS REPORTED THAT THE PATIENT HAS NOT FELT STIMULATION IN ABOUT TWO WEEKS
RESULT HER RIBS WERE CRACKED WITH (B)(6). THE PATIENT WAS PRESCRIBED LEVAQUIN FOR THE (B)(6) 750 MG (1 PILL) AND
WAS CHARGED AND SHOWED THE RECHARGER NEEDED TO BE CHARGED. THE RECHARGER WAS PLUGGED IN AT THE TIME OF
THE SCREEN WHICH WAS NOTICED THE DAY PRIOR TO THE REPORT. IT WAS SUGGESTED TO GET NEW BATTERIES FOR THE PRO
NOTED THAT SHE COULDN�T COME FROM A LAYING POSITION TO UP OR WHEN SHE TRIED TO BREATHE IS WHEN THAT PAIN
VERY SORE, THAT�S WHERE THE PAIN WAS, AND SHE COULDN �T PUT ANYTHING UP TO IT. WHEN ASKED IF THE INS WAS DE
RECHARGER. THE PATIENT STATED THAT IF THE UNIT WAS WORKING, THEN THE PATIENT FELT WHEN SHE WOULD GET UP THE
THE BACK OF HER LEG. THE PAIN WAS EXCRUCIATING AND SHE WAS HAVING AN ISSUE WALKING AND WAS CURRENTLY WALKI
GROIN, AND DOWN THE PATIENT�S LEGS AND IT WAS FELT THERE WAS AN ISSUE WITH THE LOWER BACK. THE PATIENT REPO
EPIDURAL BUT AN EPIDURAL WAS NOT GIVEN BECAUSE IT WAS AN EMERGENCY. THE DOCTOR TOLD THE PATIENT SHE WAS SO
DOCTOR SHE COULDN�T WALK AND COULDN�T FEEL ANYTHING. SHE WAS PUT INTO A WHEELCHAIR AND TAKEN OUT TO H
HOURS UNTIL SHE THOUGHT SHE COULD DO SOMETHING BUT DIDN �T FEEL ANYTHING UNTIL ABOUT 1 A.M. THIS WAS THE F
ANYTHING.� SHE FELT BETTER THE NEXT DAY AND HADN �T HAD THIS ISSUE UNTIL THE PATIENT WENT TO RECHARGE TWO W
THE SCREEN DIDN�T MAKE SENSE TO HER BECAUSE SHE COULDN �T REACH AROUND TO HER INS TO CHECK IT. NO INTERVEN
3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLAN
45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N263643, IMPLANTED: (B)(6) 2
WAS AFRAID THAT HER UNIT WAS DAMAGED BECAUSE SHE COULD NOT CONNECT WITH THE RECHARGER. THE PATIENT HAD P
EMERGENCY ROOM (ER) ON (B)(6) 2014. THE PATIENT HAD AN APPOINTMENT WITH THE PHYSICIAN ON THE DAY OF THE REPO
SEEN BY THE MANUFACTURING REPRESENTATIVE BEFORE THE HOLIDAYS. THEY WERE ABLE TO JUMP HER BATTERY, ALTHOUGH
NO DATE WAS SET FOR THE REPLACEMENT.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. P
PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4),
INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS NOT WORKING RIGHT AND THE DOCTOR HAD PUT THE LEADS IN T
(INS) WAS REMOVED AND TAKEN OUT, AND THE LEADS WERE STILL IN. THE BATTERY WAS WAY TOO HIGH AND TOO CLOSE TO
LEG AND THE DOCTOR HAD HIT A NERVE. THE HEALTHCARE PROVIDER (HCP) SAID IT WOULD BE BETTER IN A COUPLE OF DAYS
SHE FELL DOWN HER STAIRS AND TORE HER ROTATOR CUFF. THE HCP COULD NOT SEE ON X-RAY, SO THEY WANTED TO DO AN
HER HCP THAT SHE COULD NOT GET ANOTHER INS. THE PATIENT WANTED TO CONSULT WITH ANOTHER HCP. THE PATIENT IND
CALLER, THE PATIENT STATED THAT THE INS WAS REMOVED BECAUSE �IT WAS NOT PUT IN RIGHT �, BUT THE CALLER DID NO
REMOVED THE INS. INQUIRY WAS MADE INTO AN MRI OF THE SHOULDER. NO OUTCOME WAS REPORTED REGARDING THIS EV
SENT.
WRONG LOCATION AS THE IMPLANTABLE NEUROSTIMULATOR (INS) �WASN �T LINED UP RIGHT � AND WOULD PROVIDE TO
STIMULATION WASN�T GOING ALL THE WAY DOWN TO THEIR FOOT ALL THE TIME AND IT DEPENDED ON THE SLIGHTEST MO
IMPLANT. THE PATIENT HADN�T BEEN ABLE TO FEEL ANYTHING A LOT OF THE TIME AND THEN THEY WOULD PUT IT ON �40
STIMULATION ON KIND OF HIGH BECAUSE THEY DIDN �T REALLY FEEL ANYTHING. THE PATIENT HAD AN EXCRUCIATING PAIN O
TIME OF THE REPORT. THE PATIENT ALSO HAD EXCRUCIATING HEADACHES, DIZZINESS, AND BLURRED VISION. THE PATIENT HA
SPINAL CORD STIMULATION (SCS) HAD NOT BEEN �FIXED. � LATER, A MANUFACTURER REPRESENTATIVE WAS ABLE TO GET T
THE STIMULATION IN THE GROIN AREA AND �SOMETHING HAD TO BE DONE ABOUT IT. � THE PATIENT HAD HAD NO FALLS O
BOX� BUT THE PATIENT DIDN�T SEE A CHECK MARK ON THE SCREEN INDICATING WHAT PROGRAM THEY WERE ON AND IT A
DURING WHICH THE PATIENT�S HEAD �WENT FORWARD AND ALL THE WAY BACK. � IT WAS STATED THAT DURING THE CAR
INCONTINENCE DUE TO THE STIMULATION IN HER GROIN, WHICH HAD STARTED 2 MONTHS PRIOR TO THE (B)(6) . THE PATIEN
IN HER LEG AND WAS CAUSING THE PATIENT �S KNEE TO BEND THE WRONG WAY. THE PATIENT HAD BEEN TOLD TO TURN THE
PATIENT STILL HAD CONCERNS WITH THE DEVICE OR THERAPY, BUT WAS WORKING WITH A HEALTHCARE PROVIDER (HCP) OR
EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATI
IT WAS REPORTED THE PATIENT WAS IN THE ER FOR PAIN AND SWELLING AROUND THE IMPLANT SITE. IT WAS NOTED THE HEA
NERVE STIMULATOR FOR LOWER EXTREMITY PAIN. THE PATIENT REPORTED THAT ON (B)(6) 2014 THE INCISION WHICH WAS HE
HER SON AT HER BEDSIDE AND BROUGHT IN PATIENT �S SCANNER FOR HER STIMULATOR TO TURN IT OFF FOR AN MRI TEST T
SIGNIFICANT ARTIFACT FROM THE STIMULATOR DEVICE EXTENDING FROM T12-L3. HOWEVER AT THE T12 LEVEL TO THE RIGHT
COULD REPRESENT A SMALL ABSCESS. THE PATIENT CAME TO ED FOR EVALUATION OF LOWER BACK PAIN THAT RADIATED TO R
DRAINAGE 5 CM SCAR NOTED WITH A BULGE PROTRUDING AT THE TOP. IT WAS STATED �NON-FUNCTIONAL NEURO STIMULA
AT THE SURGICAL INCISION SITE. IT WAS STATED THAT THIS COULD BE A FLUID COLLECTION OR A SMALL ABSCESS RELATED TO
TREAT THE ABSCESS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRO
TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
IT WAS REPORTED THE PT BEGAN EXPERIENCING A LOSS OF MOBILITY TWO MONTHS AFTER BEING IMPLANTED. SEVERAL MO
THE EXACT DATE OF EXPLANT IS UNK. SINCE EXPLANT, THE PT HAS BEEN USING A WHEELCHAIR AND A WALKER. SJM HAS LIMI
HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
PRODUCT ID 97740, SERIAL# (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYP
COUPLING PROBLEM. THE PATIENT STOPPED FEELING STIMULATION ON THE NIGHT PRIOR TO REPORT AND HER LEFT LEG AND
AND WAS NOT HAVING ANY SUCCESS. THE PATIENT WAS GETTING 0 COUPLING BARS. THE PATIENT STATED THAT SHE HAD BEE
WAS SNUG. THE PATIENT STATED THAT THERE WAS NO SWELLING OR BANDAGES. THE PATIENT STATED THAT SHE HAD TRIED M
DOWN AS WELL. THE PATIENT WAS IN A WHEELCHAIR. THE PATIENT STATED THAT SHE HAD TRIED PROPPING A PILLOW AGAIN
WAS ON AND PUTTING PRESSURE AGAINST IT. NONE OF THESE SEEMED TO MAKE A DIFFERENCE WITH THE COUPLING LEVEL.
SHADED. THE PATIENT MENTIONED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD ALREADY INCREASED SIN
(B)(4). CONCOMITANT: PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE LEAD, PRODUCT ID 37746, SERIAL# (B)(4), PRODU
2012-(B)(6), PRODUCT TYPE LEAD. (B)(4). IT WAS REPORTED THAT THERE WAS NO STIMULATION SENSATION IN THE PATIENT�
PROGRAMMER AND USUALLY EVERY 4-5 DAYS THEY INCREASED THE SETTINGS BUT YESTERDAY THEY WENT TO USE THE PATIEN
SENSATION. NORMALLY THE SETTING WAS AT PROGRAM A AROUND 2.9. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CO
THE PATIENT SWITCHED TO PROGRAM B, FOR THE LEFT LEG, AND INCREASED THE STIMULATION FROM 4.4 TO 7.0 AND STILL H
UTILIZED AN ELECTRIC SCOOTER AND HAD BEGUN INCREASING HIS PHYSICAL THERAPY EXERCISES RECENTLY WITH WALKING O
GOT A NEW BED ABOUT 6 MONTHS AGO AND REPORTED THAT WHEN THE PATIENT GETS UP HE HAD TO DRAG HIMSELF TO GE
THEY WENT BACK TO A REGULAR BED. THERE WERE NO REPORTS OF A FALL OR TRAUMA. IT WAS NOTED THAT THE PATIENT U
TESTED. REFERENCE, 1: ELECTRODE 9 - 312 OHMS AND ELECTRODE: 5 AND 6 >20K OHMS, 2: ELECTRODE 10 - 321OHMS AND E
AND 6 >20K OHMS, 5: ELECTRODE 13 - <(><<)>50 OHMS AND ELECTRODE: 5 AND 6 >20K OHMS, 6: ALL ELECTRODES >20K OHM
OHMS, 9: ELECTRODE 1 - 312OHMS AND ELECTRODE: 5 AND 6 >20K OHMS, 10: ELECTRODE 2 - 321OHMS AND ELECTRODE: 5 A
OHMS, 13: ELECTRODE 5 - <(><<)>50 OHMS AND ELECTRODE: 5 AND 6 >20K OHMS, 14: ELECTRODE15 - 252 OHMS AND ELECT
PATIENT FELT NO STIMULATION UP TO 9V. THEY REPROGRAMMED USING 0-2+ AND UP TO 9.5V AND THE PATIENT CONTINUED
AREA, STIMULATION UP TO 9V. THE PATIENT STIMULATION WAS TO COVER HIS RIGHT LEG AND HIS RIGHT FOOT TO HIP AREA.
MANUFACTURER REPRESENTATIVE WAS AWAITING NOTIFICATION FROM THE PHYSICIAN OR THE PATIENT. NO OUTCOME WAS
RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT AS OF THE WEEK PRIOR TO THE REPORT THE PATIENT HAD NOT RECOV
PATIENT. PRODUCT ID 39286-65, PRODUCT TYPE: LEAD. PRODUCT ID 39286-65, PRODUCT TYPE: LEAD. CONCOMITANT: PRODU
TYPE PROGRAMMER, PATIENT. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_LEA
NO FEELING IN HER LEGS AND OR LOWER BODY SO THE HEALTHCARE PROVIDER (HCP) IMMEDIATELY REMOVED THE DEVICE A
HER OWN AND WAS BEING CATHETERIZED AND WAS CURRENTLY IN PHYSICAL REHABILITATION AT THE HOSPITAL. THEY WERE
ISSUE AFTER THE IMPLANT, AND HAD NO IDEA IF THE PATIENT �S LOSS OF FEELING WAS CAUSED BY THE SPINAL CORD STIMU
SURGEON�S ASSISTANT. THE PATIENT WAS STILL CURRENTLY IN PHYSICAL REHABILITATION AT THE HOSPITAL. THE CAUSE OF T
NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORM
PRODUCT TYPE: LEAD. PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 39286-65, PROD
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SE
ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). (B)(4). FOLLOW UP FROM THE CONSUMER
WAS NOTED THAT THE CONSUMER WAS CHARGING EVERY WEEK. THE CONSUMER NOTED THAT SHE HAS TO CHARGE ON MON
A CALL YOUR PHYSICIAN ERROR SCREEN AS WELL. THE CONSUMER HAD NOT RECENTLY BEEN REPROGRAMMED BUT HAS HAD
BUT AT THE TIME OF THE REPORT THEY HAD TO INCREASE IT TO 5.6 V OR HIGHER IN ORDER TO GET STIMULATION. THE CONSU
CARE PROVIDER OF HER CONCERNS AND THERE IS NO PLANNED INTERVENTION. SHOULD ADDITIONAL INFORMATION BE RECE
THEIR DEVICE THE PREVIOUS WEDNESDAY NIGHT UNTIL 1:30 AM THURSDAY MORNING. THE PATIENT SAW THE TEAR DROPS O
KNEE REPLACEMENT SURGERY ON THE THURSDAY PRIOR TO THE REPORT AT 7:30 AM AND THEY TURNED THEIR IMPLANTABLE
PATIENT NOTED THAT THEIR INS WAS DEPLETED ON SATURDAY BUT LATER NOTED THAT THEY SAW THE INS WAS DEPLETED ON
DEPLETED. THE PATIENT WAS UNABLE TO CHARGE UNTIL SATURDAY WHEN THE PATIENT �S HUSBAND GOT A RECHARGER FOR
GOT UP ON THE MORNING OF THE REPORT THEY HAD NO CHARGE AGAIN. THE MONTH PRIOR TO THE REPORT THAT PATIENT�
HAD NOT CHARGED. THE PATIENT GOT THEIR PROGRAMMER AND NOTED THAT THE PROGRAMMER BATTERY WAS FULL AND T
AN �INS BATTERY LOW SCREEN� ON THEIR PROGRAMMER. THE PATIENT GOT THEIR RECHARGER AND NOTED THAT THEIR IN
COUPLING WENT FROM 8 BARS TO 4 BARS TO 2 BARS. THE PATIENT NOTICED THESE ISSUES WITH CHARGING AFTER THEIR KNE
INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. .
IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE PHYSICIAN �S OFFICE IN (B)(6) 2014 FOR A POST-OPERATIVE APPOINT
PATIENT�S WIFE THEN CONTACTED THE MANUFACTURER �S REPRESENTATIVE ON THE MORNING OF (B)(6) 2014 WHERE IT W
ADDITIONAL SYMPTOMS OF LOSS OF REFLEXES IN THE LOWER EXTREMITIES AND PARALYSIS WERE REPORTED. THE PATIENT W
EXPLANTED THE ENTIRE INS SYSTEM ALONG WITH A NON-FUNCTIONING SYSTEM OF ANOTHER MANUFACTURER. IT WAS NOT
COMPRESSING� WAS SEEN DURING THE SURGERY. CULTURES THAT WERE TAKEN GREW �REGULAR � STAPH. ON FOLLOW U
FAR AS POTENTIAL COMPLICATIONS FROM THE INS SYSTEM. A NEUROLOGIST WAS BEING CONSULTED SINCE ALL TESTING WAS
TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCOMITANT MEDICAL
SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1132, SERIAL (B)(4), DESCRIPTIO
MEDICAL FACILITY. A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO EXHIBITING P
INJURY TO THE SPINAL CORD. THE NEUROSURGEON THOUGHT THAT THERE MAY HAVE BEEN DAMAGE TO THE SPINAL CORD A
PHYSICIAN BELIEVED THAT THE PARALYSIS WAS CAUSED BY THE IMPLANT PROCEDURE. THE PATIENT COULD NOT FEEL ANYTHI
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS NOT PARALYZED AND THERE WAS NO NEUROLOGICAL DE
UNKNOWN AND FIBROSIS HAD CAUSED THE IMPLANT DIFFICULTY. NO OTHER MALFUNCTIONS WERE NOTED AND THE PATIEN
COATING OF THE LEADS. ADDITIONALLY THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET HAD BEEN TOO SMALL. A FLIP W
INCISIONAL WOUND OPENING AND PARALYSIS. IT WAS ALSO INDICATED THAT THE PATIENT EXPERIENCED LESS THAN 50% THE
IN 2012, THE PATIENT HAD THEIR INS REPLACED AND THEY HAD A NEW TIME OF INS IMPLANTED. THE PATIENT WAS TOLD THE
EXISTING POCKET TO THE RIGHT OF THE PATIENT �S ABDOMEN. SINCE IMPLANT THE INS HAD CAUSED IRRITATION AND BEND
THEY MOVED AROUND. THERE WAS ALSO FLUID RETENTION AROUND THE INS AND THE INS DID NOT FIT WELL IN THE EXISTIN
PICKING SOMETHING UP AND THE INS TORE OUT OF THE POCKET. THE INS HAD DROPPED DOWNWARDS AND TILTED TO THE S
BACK ALONG THE PATH OF THE �GUIDE WIRE. � THE PATIENT HAD PAIN IN THEIR BACK WHERE THE �GUIDE WIRE � WAS P
THE INS WAS DONE AT THE END OF (B)(6) 2014, BUT IT DID NOT GO WELL. THE TISSUE SURROUNDING THE POCKET WAS REAL
POCKET COULD NOT BE REPAIRED SO THE INS WAS RAISED UP AND ATTACHED TO THE FASCIA WITH SUTURES. AT A FOLLOW U
HAD NOT DEPLETED AND WAS ESTIMATED TO LAST UNTIL THE END OF 2014 OR THE BEGINNING OF 2015 WHICH WAS WHEN
SKIN AGAIN AS THE INS HAD DROPPED AND TILTED. THE SUTURES ON THE FASCIA HAD NOT HELD THE INS AND THE POCKET LO
LOCATED UNDER THE BLISTER AND THERE WAS NO PROPER SKIN COVERING IT. THE INS WAS REPLACED AND THE POCKET WAS
LOCATION IN THE PATIENT�S ABDOMEN COULD NOT BE USED AND THE INC COULD NOT BE REMOVED VIA THE OLD SCAR. TH
THE REVISION, THE �ELECTRODES AT THE BACK FELL OUT DUE TO ACIDIFICATION � AND THEY HAD TO BE REMOVED. A �PU
PROFESSIONAL (HCP) TRIED A LITTLE HIGHER AND THE LEADS WERE EVENTUALLY PLACED AT THE LEVEL OF T12. FOLLOWING T
ABDOMINAL MUSCLES AND THEY WERE RESTRICTED IN MOVEMENT WHEN BENDING, TURNING THEIR TRUNK, AND STRETCHI
PATIENT�S ALREADY POOR CONDITION AND HAD CAUSED A LOT OF STRESS. THE INS WAS WORKING FOR THE PATIENT AS TH
THESE ISSUES. . CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TY
IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS WITH HER IMPLANTABLE NEUROSTIMULATOR (INS) AND THOU
FLIPPED OR MOVING OR INFECTED, BUT IT WAS PAINFUL TO THE TOUCH. SHE THOUGHT SHE DIDN �T HAVE THE FAT OR THE M
REJECTING THE INS BECAUSE IT WAS SUPER SORE AND NEVER STOPPED HURTING. IT WAS NOTED THAT IT WASN �T RED OR S
TO PAIN ISSUES. THE INS WAS MOVED FROM THE UPPER PART OF HER BUTTOCKS TO MORE ON THE SIDE OF HER HIP. THE PAT
UNABLE TO SEE HER MANAGING HEALTHCARE PROVIDER (HCP) UNTIL ABOUT 2 MONTHS LATER, BUT SHE WAS TRYING TO SEE
REALLY BAD. SHE WAS GOING TO HAVE TO �CRANK THIS UP TO CONTROL THE PAIN THAT �S IN MY HIP RIGHT NOW � BUT T
�CRANKS� STIMULATION UP HIGH ENOUGH TO HELP THE PAIN IN HER HIP. THE PAIN IN HER HIP HAD BEEN GOING ON FOR
MACHINE IS AT.� THE PATIENT� DIDN�T KNOW WHAT HAD HAPPENED. EVEN THOUGH SHE HAD ALWAYS HAD SORENESS T
IF SHE HAD TO GO EVERY YEAR OR 2 TO HAVE THE INS REPLACED OR MOVED. SHE WONDERED IF SHE WAS NOT A GOOD CAND
THE MANAGING HCP. THE PATIENT INQUIRED ABOUT THE OPTION OF HAVING THE PAIN PUMP IMPLANTED. ABOUT A WEEK LA
REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORM
PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B
PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).
A REPORT WAS RECEIVED THAT THE PATIENT HAD NUMBNESS, TINGLING AND PARALYSIS. THE PATIENT UNDERWENT AN EXPLA
PSYCHOSOMATIC. ALL IMAGING STUDIES PERFORMED WERE NORMAL AND THERE WERE NO EVIDENCE OF EPIDURAL HEMATO
TOES TO GROIN. HOME PHYSICAL THERAPY WAS RECOMMENDED. (B)(4). THE EXPLANTED DEVICES WERE NOT RETURNED TO B
(B)(4). IT WAS REPORTED THAT THE PATIENT GOT THEIR COMPLETE SYSTEM REMOVED IN 2010 BECAUSE SHE WAS EXPERIENCI
WAS GETTING WORSE AND SHE WAS FALLING CONTINUALLY. INFORMATION REGARDING IF THE PATIENT STILL HAD CONCERNS
MEDICAL PRODUCTS: PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT
2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 399930, LOT# V005883, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4
CONTINUED TO FALL FREQUENTLY. THE DEVICE WAS REMOVED IN 2010 AND THE PATIENT NO LONGER HAD PARALYSIS ON THE
REMOVED BY A DIFFERENT DOCTOR. THE PATIENT WAS BEING SEEN AT A SPINE CENTER SINCE REMOVAL OF THE DEVICE.
IT WAS REPORTED THE PATIENT WAS IN HER WHEELCHAIR WHEN SHE BACKED UP AND HIT HER DRESSER AND HER STIMULATI
WHEN SHE STOOD UP, STIMULATION INCREASED AND CAUSED HER LEFT KNEE TO GO OUT. THIS HAPPENED MOST RECENTLY A
CHARGE, SO SHE CALLED AND MET WITH THE MANUFACTURER REPRESENTATIVE (REP). THE PATIENT �S ISSUE WAS SHE WAS
MONTH. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDU
PRODUCTS: PRODUCT ID 97792, LOT# N433621, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 39565-65
ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). (B)(4). IT WAS REPORTED THE PATIENT REPORTEDLY HAD A LOT O
SHOULDER OUT TWICE. OF NOTE: INFORMATION THAT WAS PREVIOUSLY REPORTED HAS BEEN OMITTED FROM THIS REPORT.
REPORTED HAVING MULTIPLE SEIZURES THAT HER MEDICATION WAS NOT CONTROLLING. SHE COMPLAINED OF VNS NOT SPIN
THOUGHT HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. THE REP MET WITH THE PATIENT ON (B)(6) 2
CHECKED THE PROGRAMMING AND IMPEDANCES. THE PROGRAMS WERE NOT CHANGED. THE PATIENT REPORTED APPROPRIA
ANYTHING REGARDING THE PROBLEMS WITH THE SCS INCREASING OR DECREASING WHEN IT WASN'T SUPPOSED TO. THE PAT
IMPEDANCES WERE WITHIN NORMAL LIMITS. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE ISSUE WAS REPORTEDLY
PRODUCT ID: 74001, LOT# N475473, SERIAL# IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER. PRODUCT ID: 7425, SERIAL#
IMPLANTED: (B)(6) 1995, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434-E, SERIAL# (B)(4) IMPLANTED: (B)(6) 1999, PRODUC
(B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7496-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYP
REPORTED THAT THE PATIENT HAD SCHEDULED AN APPOINTMENT TO BE SEEN BY THE DOCTOR WHO REPLACED THE BATTERY
ISSUE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED FOR THIS INFORM
2014 BUT ALSO SAW THE PATIENT �MANY MONTHS AGO. � SINCE THE PREVIOUS SESSION THE PATIENT HAD A BATTERY REP
THE FIRST FOUR WEEKS FOLLOWING REPLACEMENT THE PATIENT COULD FEEL STIMULATION BUT NOW NOT AT ALL. REPROGR
THAT THE #1 ELECTRODE OF A FOUR CONTACT LEAD HAD �NOT BEEN WORKING. � AT THAT TIME, IT WAS REPROGRAMMED
>10,000 OHMS. THE OTHERS WERE AT 700 OHMS. IT WAS KNOWN THAT IT WAS NOT THE POCKET ADAPTER BECAUSE THAT W
MENTIONED THAT THE PATIENT WAS IN A WHEELCHAIR. THE CALLER WOULD DISCUSS SURGICAL REPLACEMENT WITH THE PH
RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT # 3004209178-2014-12186 REGARDING T
TROUBLE GETTING A HOLD OF THE DOCTOR.
IT WAS REPORTED THE PATIENT EXPERIENCED �REPETITIVE CONSCIOUSNESS LOSS EVERY FEW MINUTES � AND �TEMPORA
PATIENT REPEATEDLY LOSING CONSCIOUSNESS.� THERE REPORTEDLY �APPEARED NO RELATION WITH THE STIMULATION. �
HAD REPORTEDLY BEGAN EXPERIENCING �LOWER LIMB WEAKNESS � IN (B)(6) 2014, HOWEVER IT WAS NOTED THAT �GUIL
WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014, THE �PATIENT WAS URGENTLY HOSPITALIZED FOR LO
DISCHARGED� THE FOLLOWING DAY. HOWEVER, THE PATIENT WAS HOSPITALIZED FOR LOWER LIMB WEAKNESS ONCE AGAIN
WAS NOTED TO HAVE BEEN �POSITIONED IN AN AREA BETWEEN THE C2 AND C3 VERTEBRAE. � THE PATIENT �S PHYSICIAN
MIGHT NOT HAVE AFFECTED THE SYMPTOMS, THE ELECTRODES WOULD BE CHANGED TENTATIVELY � AT THE PATIENT �S NEX
THE GENERAL MEDICINE DEPARTMENT VIEWED SCS AS A CAUSE OF THE EVENT. � IT WAS NOTED AT THE TIME OF REPORT TH
CORD INFARCTION, AND DIABETES� AND �AS SUCH, THE PATIENT MAY HAVE BEEN TAKING SEVERAL DRUGS. � THE PATIENT
WAS FURTHER REPORTED THAT �MEDICAL HEALTH PROVIDERS A TTRIBUTED THE DIZZINESS � TO THE ADVERSE EVENT OF T
DIZZINESS IN (B)(6) 2014, POSSIBLY IN (B)(6) 2014, AND FROM (B)(6) 2014. IT WAS NOTED THAT AT THESE TIMES �NO LOSS O
DIZZINESS� WAS �POSSIBLY AN ADVERSE EVENT OF THE ANTIEPILEPTIC MEDICATION � THE PATIENT HAD BEEN PRESCRIBED
FAINTING IN (B)(6) 2013. AS OF NINE DAYS AFTER THE INITIAL REPORT, IT WAS NOTED THE CAUSE OF THE EVENT REMAINED U
UNDER MONITORING AT THAT TIME AND THE DEVICE SYSTEM REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN
3487A-33, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 748266, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).
A REPORT WAS RECEIVED THAT THE PATIENT HAD LOST HIS MOTOR SENSATION AND WAS NOT ABLE TO MOVE HIS LEGS AFTER
PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS ABLE TO HAVE HIS MOTOR SENSATION AND MOVE HIS LEG
SPECTRA IMPLANTABLE PULSE GENERATOR. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDE
IT WAS REPORTED THAT IN (B)(6) 2009 THE PATIENT WAS GETTING AN IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM PLACE
HER ARMS AND FINGERS AND HAD TO RELEARN EVERYTHING. HOWEVER, THE PATIENT �S HEALTHCARE PROVIDER (HCP) DID
HAVE SERIAL NUMBERS AND ALSO DID NOT MENTION PARALYSIS, BUT NOTED THE PATIENT HAD PAIN IN THE ARMS AND NUM
REFERRING TO THE INS THAT WAS ALREADY IMPLANTED ON (B)(6) 2008 OR THE INS THAT WAS ATTEMPTED TO BE IMPLANTED
SHIELDED. DERMABOND ISLAND DRESSING WAS APPLIED AT THE POSTERIOR NECK AND LEFT BUTTOCK. TWO BANDAIDS WERE
IT WAS NOTED THAT THERE WAS SPACE IN HER C-SPINE AND THAT WAS WHY SHE WAS TRYING STEROID INJECTIONS. BECAUSE
REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITION
2014-16687 CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID:
IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE PATIENT WAS SCHEDULED FOR STEROID
PATIENT THEN WOKE UP TO EXCRUCIATING BUZZING AND PAIN IN HER LEGS, ARMS AND TORSO. ALL OF HER VITALS WENT EXT
COULDN�T COMMUNICATE THIS TO THE HEALTHCARE PROVIDER (HCP) STAFF WHO WERE TRYING TO NORMALIZE HER VITAL
HOWEVER, WHEN SHE GOT HOME THE PATIENT CHECKED THAT HER STIMULATION WAS OFF. THE PATIENT CHECKED HER DEVI
WAS NOTED THAT THE PATIENT HAD NOT HAD HER DEVICE CHECKED OR ADJUSTED SINCE 2011 AND SHE HAD 7 PROGRAMS W
SPINE. �THE PATIENT�S LEFT ARM WAS HURTING UNDERNEATH, SAID THEY HAD TO PLACE HER ON TABLE INSTEAD OF TABL
THEY USED X-RAY WHILE GIVING THE INJECTION TO THE PATIENT. THE PATIENT WAS OFF BALANCE BECAUSE STIMULATION WA
TO SPEAK AND THEY TOLD HER THEY DIDN �T KNOW WHAT HAPPENED. IT WAS NOTED THAT THE PATIENT HAD FELT A SIMILA
INJECTION, THE PATIENT�S STIMULATION WAS ON, BUT AFTERWARD IT HAD TURNED OFF WITHOUT USING A CONTROLLER.
SUPERCHARGED JOLT. SHE COULDN�T MOVE HER LEGS AND URINATED ON HERSELF, AND WAS IN SEVERE PAIN; THE PATIENT
AND TURNED THE INS ON, SHE FELT A GREATER STIMULATION SENSATION (SIMILAR TO A NEW LEAD IMPLANT). THE PATIENT H
INFORMATION RECEIVED REPORTED THAT THERE WAS NOW A 50% OR GREATER SYMPTOM REDUCTION. IMPEDANCES WERE C
DETERMINED. REPROGRAMMING WAS NOT NEEDED AND THE PATIENT WAS DOING FINE AND RECEIVING EFFECTIVE THERAPY
IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE:
(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRO
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN MRI AND �ALL WAS NORMAL WITHIN RANGE OF THE
THE LEGS, OR WHAT FELT LIKE TINGLING AND A LOSS OF FULL MOVEMENT. � IT WAS NOTED THAT THE TRIAL WAS �A NORM
THAT THE PATIENT HAD BEEN TAKEN FOR A CT SCAN, BUT RESULTS HAD NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION
(HCP) NOTED THE SYMPTOMS WERE RELATED TO THE PATIENT'S MS AND NOT THE DEVICE OR THERAPY. AN MRI WAS DONE A
REGAINED BASELINE MOVEMENT TO THEIR LOWER EXTREMITIES WITHIN 24 HOURS AND THE PATIENT WAS LOOKING TO HAVE
UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MRI RESULTS HAD NOT YET BEEN RECEIVED. CONCOMITANT MED
SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3887-45, LOT# J0421678V, IMPLANTED: (B
(B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B
REPORTED THE PATIENT�S LEADS WERE REMOVED, BUT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS STILL IMPLANTED
HAD A SUDDEN ONSET OF PARALYSIS ABOUT 3 DAYS PRIOR TO THE DATE OF THE REPORT; A LAMINECTOMY WAS PERFORMED
PROFESSIONAL (HCP) DID NOT THINK THE SPINAL CORD STROKE WAS RELATED TO THE SPINAL CORD STIMULATION (SCS) SYST
TO MANUFACTURER REPORT # 3004209178-2014-16007. .
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MRI RESULTS HAD NOT YET BEEN RECEIVED. CONCOMITANT MED
IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD; PRODUCT ID 7427, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: IM
(B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRO
377775, LOT# V004859, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 3887-45, LOT# J0421678V, IMPLANTED:
PRODUCT ID 3887-45, LOT# J0421678V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD; PRODUCT ID 377775, LOT# V004859,
NEUROSTIMULATOR (INS) WAS STILL IMPLANTED. MRI COMPATIBILITY GUIDELINES WERE REQUESTED. ADDITIONAL INFORMAT
THE REPORT; A LAMINECTOMY WAS PERFORMED THE FOLLOWING DAY BUT THAT DID NOT HELP AND PARALYSIS HAD NOT IM
TO THE SPINAL CORD STIMULATION (SCS) SYSTEM AND THEY INTENDED TO REMOVE THE INS SO THEY COULD PERFORM A FU
CONCOMITANT PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODU
RECHARGER. PRODUCT ID: NEU_SILICONE ANCHOR, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSOR
(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE
NEUROSTIMULATOR (INS) FOUND THAT THERE WAS NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE INS WAS FUNCTION
RECEIVED REPORTED THAT THE PATIENT WAS BETTER SINCE EXPLANT. THE PATIENT WAS STILL IN A WHEELCHAIR. THE PATIENT
THERAPY. . IT WAS REPORTED THAT THE PATIENT REPORTEDLY HAD NAUSEA AND VOMITING THAT BEGAN TWO WEEKS FOLLOW
WEAKNESS AND HAD BEEN WORKED UP BY THE SURGEON. THERE WAS NO KNOWN REASON FOR THE WEAKNESS. IT WAS ALS
HAD SWELLING OVER THE TUNNELING TRACT THAT HE REPORTED TO THE SURGEON. IT WAS NOTED THAT UPON REMOVAL TH
WITHIN A NORMAL RANGE. THERE WERE NO TENDER AREAS UPON PALPATION EXCEPT THE TRACT OF THE LEAD BETWEEN AN
SEEN THROUGH THE LIFE OF THE DEVICE BY DIFFERENT TEAM MEMBERS FOR REPROGRAMMING. IT WAS NOTED THAT EACH T
PATIENT REPORTED THAT STIMULATION WOULD BECOME AGGRAVATING. THE INITIAL PLACEMENT OF THE DEVICE WAS NON-E
RELIEVING STIMULATION IN THE AREAS INTENDED. THE PRODUCT STATUS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AN
WEAKNESS IN THE LOCATION DESCRIBED AS THE LEFT SIDE IMPLANT. IT WAS ALSO DESCRIBED AS ALONG THE LEAD TRACT TO
NORMAL USE. DIAGNOSTICS OR TROUBLESHOOTING INCLUDED IMPEDANCE TESTING, X-RAYS, AND REPROGRAMMING. AT TH
STIMULATION WAS ACTIVE ON ACTIVE GROUP. THE OBSERVATIONS ON THE SUMMARY REPORTED INCLUDED: STIMULATION O
STATUS WAS OKAY. THE IMPEDANCES RANGED BETWEEN 551 AND 729 OHMS. IT WAS FURTHER REPORTED THAT CYCLING WA
PATIENT. THE INTENDED USE OF THE DEVICE WAS TREATMENT. THERE WAS NO PATIENT DEATH. TWO ANCHORS WERE ALSO RE
CONCOMITANT PRODUCTS: PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID
PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (
WASN�T ABLE TO USE STIMULATION, SINCE IT CAUSED HER MORE PAIN IN HER RIGHT FOOT. THE INCIDENT OCCURRED IN (B)
PATIENT REPORTEDLY COULDN�T GET OUT OF BED DUE TO BACK PAIN AND SHE HAD TO HAVE A SHOT AT THE HOSPITAL TO R
HAD AN APPOINTMENT SCHEDULED WITH THE HCP TO DISCUSS GETTING THE DRUG PUMP. THE PATIENT �S STATUS WAS REP
REPORTEDLY IN A WHEELCHAIR BECAUSE OF SACRAL NERVE PAIN WHEN WALKING. ADDITIONAL INFORMATION RECEIVED REP
IT WAS REPORTED THE PATIENT WAS NEVER ABLE TO GET THE DEVICE ADJUSTED TO HELP THE PATIENT �S PAIN IN THE CORRE
PROGRAM THE DEVICE AND WAS NOT SUCCESSFUL. IT WAS NOTED THAT THE PATIENT HAD �EVERY REP IN PENNSYLVANIA TR
OFF.� IT WAS NOTED THE REP HAD NEVER SEEN ONE �DO THIS � WHERE SHE TRIED TO ADJUST IT �HERE � AND IT WAS H
STIMULATION OFF. THE PATIENT NOTED THAT �IT WAS SO BAD THEY HAD TO CHANGE IT, IT WAS ABOUT TO ELECTROCUTE M
FEAR OF IT SHOCKING HIM. THIS REPORTEDLY HAPPENED FROM �DAY 1. � THE PATIENT �S NEUROSURGEON REPORTEDLY T
AND THE PATIENT WOULD HAVE TO DO ALL KINDS OF PREPARATIONS BEFORE EXPLANT. � THE EXPLANT SURGERY HAD NOT B
RECOVERY� IN THE HOSPITAL FOLLOWED BY REHABILITATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SER
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE
HAD A MEDTRONIC NERVE STIMULATOR PLACED ON (B)(6) 2014. THE NEXT DAY DEVELOPED PARESIS, SEVERE PAIN AND CAUD
RETURNING.
IT WAS REPORTED THE PATIENT DEVELOPED A HEMATOMA/BLOOD CLOT IMMEDIATELY POST-OP. A PARTIAL EXPLANT WAS REQ
A PARTIAL WIRE STILL CONNECTED. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. IT WAS NOTED THAT
IN THE LOWER EXTREMITIES AND PARALYSIS AT THE LEAD LOCATION. THE PATIENT �S STATUS WAS NOTED TO BE ALIVE WITH
2014. ALL ISSUES WERE REPORTEDLY RESOLVED. THE PATIENT WAS REPORTEDLY MOVING HER LEGS AND WALKING. CONCOMI
ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECH
(B)(4). CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE:
PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A260, SERIAL# (B
WAS REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT AND OVERSTIMULATION. THE PA
ORDERED X-RAYS ON THE SAME DAY AND SOME OTHER DIAGNOSTIC TESTS TO TROUBLE SHOOT THE PROBLEMS. IT WAS UNKN
SHOWED > 10,000 OHMS. REPROGRAMMING WAS ATTEMPTED. DIFFERENT CONFIGURATIONS, PLACEMENTS, AND PULSE WID
IN THE WRONG LOCATION. THE PATIENT EXPERIENCED A BURNING SENSATION, LOSS OF REFLEXES IN THEIR LOWER EXTREMIT
NUMBNESS AND LOSS OF SENSATION IN THEIR LEFT LEG FROM THE KNEE DOWN TO THE FOOT AT THE TIME OF THE REPORT. P
WERE PRESENT AT THE DEVICE POCKET AND THE LEAD LOCATION. THE PATIENT STATUS AT THE TIME OF THE REPORTED WAS U
A SERIES OF ACTIONS TO RESOLVE THE ISSUE BUT DID NOT SHARE THEIR THOUGHT PROCESS OR PLANS WITH THE MANUFACT
ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONA
IT WAS REPORTED THAT A PATIENT HAD STIMULATION OFF AND WAS UNABLE TO RECHARGE OR CONNECT THE IMPLANTABLE
OCCURRED FOLLOWING A FALL. IT WAS STATED THAT THE PATIENT FELL ON CEMENT BASEMENT FLOOR/STEPS AND THE PATIEN
THAT STIMULATION WAS OFF FOLLOWING THE FALL AND DUE TO THE PAIN LEVEL OF THE INS SITE AFTER THE FALL, THE PATIEN
CONNECT THE INSR TO THE INS. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL (HCP) PERFORMED X-RAYS THE DAY OF
GET UP FOR �SEVERAL HOURS� AFTER THE FALL TO CALL. IT WAS REPORTED THAT AN INS OVERDISCHARGE WAS SUSPECTED
RECHARGING SESSION WAS 6 TO 12 MONTHS AGO (APPROXIMATELY 10 MONTHS AGO, AT THE TIME OF THE FALL). IT WAS NO
FELL 10 MONTHS AGO. IT WAS STATED THAT STIMULATION �DID HELP WITH PAIN BUT NOT THAT MUCH � AND THAT STIMUL
BAD AS THE FALL 10 MONTHS AGO.� IT WAS STATED THAT THE PATIENT WANTED STIMULATION ON AND TO TRY TO GET OFF
USUALLY KEPT STIMULATION �CRANKED UP TO STAY OFF OXYCONTIN, THE BUZZ DISTRACTED HER BRAIN. � IT WAS STATED T
REDIRECTED TO THE HCP. (B)(4). CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRO
SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# J0555162V, IMPLANTED: (B)(6) 2
RECEIVED REPORTED THE PATIENT IS SCHEDULED FOR REPLACEMENT ON (B)(6) 2015. IT WAS UNKNOWN IF THE PATIENT WAS
PATIENT WAS SCHEDULED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED TOMORROW. IT WAS NOTED THAT
THE INS WAS SUPPOSED TO BE REPLACED TOMORROW. SHE WANTED A MANUFACTURING REPRESENTATIVE (REP) AND HEALT
FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FO
IT WAS REPORTED THAT THE PATIENT BECAME PARALYZED FROM THE WAIST DOWN WHEN THE PHYSICIAN TRIED TO IMPLANT
NECK DOWN. THE PATIENT WAS IN THE RECOVERY ROOM AND SHE COULD NOT FEEL HER LEGS AFTER IMPLANT. THE PATIENTS
ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. . CONCOMITANT PRODUCTS: PRODUCT ID 3774
SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4). IT WAS FURTHER REPORTED TH
THE IMPLANT, THE PATIENT CONTINUED TO COME IN FOR VISITS APPROXIMATELY EVERY MONTH. THE PATIENT CONTINUED TO
PARALYSIS OTHER THAN THAT IT WAS POST IMPLANT.
THE IMPLANT CAUSED TEMPORARY PARALYSIS TO THE LEFT ARM WHEN TURNED ON, CAUSING NUMBNESS AND SHARP PAIN
IT WAS REPORTED THAT 1.5 MONTHS PRIOR TO THE REPORT THE PATIENT �S DEVICE GOT CAUGHT ON THE BOTTOM OF A WH
FURTHER REPORTED THAT THE DEVICE FLIP WAS NOT CONFIRMED BUT IT WAS BULGING ON THE CAUDAL EDGE OF THE BATTE
EXPERIENCED SOME DISCOMFORT AT THE GENERATOR SITE AS THEIR BATTERY WOULD OFTEN CATCH ON THE WHEELCHAIR. T
RECEIVING EFFECTIVE THERAPY AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS N
PRODUCTS: PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT T
ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A PERMANENT SCS SYSTEM. THREE DAYS LATER THAT PATIENT WAS HOSP
EXPLANTED. FOLLOW-UP REVEALED THE PATIENT'S ISSUES HAVE NOT RESOLVED AND THE PATIENT WILL REMAIN IN REHABILIT
CONCOMITANT PRODUCTS: PRODUCT ID 7496-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE EXTENSION; PROD
1995, PRODUCT TYPE LEAD; PRODUCT ID 7434A, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7496-6
(B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SCHEDULED AN APPOINTMENT TO BE SEEN B
REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOL
INFORMATION RECEIVED REPORTED THAT THE CALLER MET THE PATIENT (B)(6) 2014 BUT ALSO SAW THE PATIENT "MANY MON
NOW, IN OCTOBER, THE PATIENT COULD NOT FEEL STIMULATION. FOR THE FIRST FOUR WEEKS FOLLOWING REPLACEMENT TH
WHEN THE CALLER PREVIOUSLY MET WITH THE PATIENT SHE DISCOVERED THAT THE #1 ELECTRODE OF A FOUR CONTACT LEAD
THE PATIENT WAS AT AN AMPLITUDE OF 8 OR 9V AND #1 WAS STILL >10,000 OHMS. THE OTHERS WERE AT 700 OHMS. IT WAS
COULD FEEL A JOLTING SENSATION EVERY ONCE IN A WHILE. IT WAS MENTIONED THAT THE PATIENT WAS IN A WHEELCHAIR. T
UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. . ANALYSIS OF THE
NOTED THAT THE DEVICE WAS ABLE TO INCREASE AND DECREASE THE IMPLANTABLE NEUROSTIMULATOR (INS) ON THE MANU
REPORT. IT WAS REPORTED BY THE PATIENT THAT HE HAD A �TENS UNIT IMPLANTED IN HIM THAT SHOCKS ELECTRICAL SIGNA
STIMULATION WAS ON AND THE PATIENT STATED �NO� AND HE WAS �JUST DESCRIBING IT AS IT WAS DESCRIBED TO HIM
RECALL HOW TO TURN ON AND OFF THE STIMULATION. THE PATIENT STATED THE HEART BYPASS SURGERY WAS (B)(6) 2014. TH
LONG.� THE PATIENT NOTED THAT HE MISSED THE STIMULATOR. THE PATIENT STATED HE HAD �A LOT � OF PAIN AS OF THE
THE PATIENT HAD A NERVE BLOCKAGE. THE PATIENT ALSO STATED THAT HE �JUST HAD A DOPPLER DONE THIS MORNING WH
JUST CHANGED THE 9V BATTERY PRIOR TO CALLING. PATIENT SERVICES WALKED THE PATIENT THROUGH A SELF-TEST TO CHEC
THE IMPLANT AND HAD THE PATIENT PRESS THE TOP BLUE KEY TO TURN ON STIMULATION. THE PATIENT PRESSED THE TOP BL
UP ARROW AND WAS NOT HEARING ANYTHING. HOWEVER, THE PATIENT NOTED THAT HE WAS PRESSING IT �ONE AT A TIME
PROGRAMMER. THE PATIENT WAS ABLE TO INCREASE UP BUT NOTED HEARING �TRIPLE BEEPS. � THE PATIENT WAS ABLE TO
THE TRIPLE BEEPS. IT WAS REVIEWED THAT THE UPPER LIMIT HAD BEEN REACHED. THE PATIENT WAS REDIRECTED TO THE HEA
PROGRAMMING BECAUSE OF A HEART BYPASS SURGERY IN (B)(6) WHERE THE PATIENT HAD TURNED STIMULATION OFF. IT WA
PATIENT TRIED THE PATIENT PROGRAMMER AND COULD NOT TURN STIMULATION UP. IT WAS NOTED THAT THE PATIENT DID N
ON (B)(6) 2014 AND NOTED NO MESSAGES ON THE CLINICIAN PROGRAMMER. IMPEDANCES WERE ALSO RUN AND ONE ELECT
AND 0-2-. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO TURN STIMULATION UP AND DOWN WITH THE CLINICIAN PRO
A BIG INCREASE FOR THE PATIENT.� IT WAS NOTED THAT �IT TOOK HIS BREATH AWAY FOR A SECOND. � IT WAS NOTED THA
A CHANGE IN STIMULATION. IT WAS NOTED THAT THERE WAS �NOTHING SHOWING NO SHORTS INDICATED. � THERE WERE
SURGERY. THE CALLER REPORTED THAT THE PATIENT STATED HE HAD VISITED AN EMERGENCY ROOM BECAUSE OF INCREASE IN
PROGRAMMER WOULD NOT INCREASE OR DECREASE THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE P
HAD NOT USED IT UNTIL �NOW.� IT WAS NOTED THAT THE PATIENT WAS UNCOMFORTABLE. IT WAS NOTED THAT THE BATT
MORNING OF (B)(6) 2014. THE PATIENT STATED THE MANUFACTURER REPRESENTATIVE FOUND THAT THE PATIENT HAD �A W
FEELING STIMULATION. THE PATIENT ALSO STATED �EVERY ONCE IN A WHILE IT WOULD KICK ON BUT THEN IT SHUT OFF AGA
(6) AND TURNED STIMULATION OFF FOR IT. THE PATIENT STATED A �WEEK OR SO � AFTER THE SURGERY HE TRIED TO TURN
PATIENT STATED HE HAND NOT SPOKE TO THE FOLLOW-UP HCP ABOUT THIS YET. THE PATIENT WANTED TO SPEAK WITH THE M
PATIENT. THE PATIENT WAS REDIRECTED TO THE HCP. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE A
DOCTOR.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT BECAUSE OF WHERE THE IMPLANTABLE NEURO
THROUGH THE SKIN AFTER IMPLANT. THE PATIENT HAD TO HAVE THE INS MOVED IN (B)(6) 2015. NOW, THE INS WAS IN HIS ST
SKIN. IT WAS NOTED THE PATIENT HAD FULLY RECOVERED, AND THAT THIS WAS A GRADUAL CHANGE IN SYMPTOMS AT THE IN
WAS NOTED THAT A REVISION WAS REQUIRED AS A RESULT AND THE BATTERY WAS MOVED IN SURGERY. IT WAS NOTED THAT
FURTHER REPORTED THAT IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SIN
LEAD. PRODUCT ID: NEU _PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: NEU_RECH
PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IM
(B)(4); PRODUCT TYPE RECHARGER PRODUCT ID A01411002, SERIAL# UNKNOWN; PRODUCT TYPE RECHARGER. (B)(4). IT WAS
WAS NOTED THAT THEY WERE ABLE TO ACQUIRE EIGHT COUPLING BOXES AND THEN ZERO AND THEN EIGHT AGAIN. THE MAN
TRY A DIFFERENT RECHARGER BUT DID NOT HAVE ONE WITH. THE CALLER BELIEVED THE MANUFACTURER REPRESENTATIVE C
420. . IT WAS REPORTED, THE STIMULATOR CHARGE WAS ONLY LASTING EIGHT TO NINE HOURS. IT WAS LATER REPORTED, THE
PATIENT FLINCHED DURING RECHARGE. IT WAS REPORTED, THE PATIENT GOT A PRETTY GOOD CHARGE FOR SEVEN HOURS THE
WHEELCHAIR, SO THE STIMULATOR WAS PRESSED AGAINST CONSTANTLY. IT WAS NOTED, THE PATIENT COULD NOT RECHARGE
NOT MAKE ADJUSTMENTS BOTH WITH AND WITHOUT THE ANTENNA ATTACHED. IT WAS REPORTED, THE PATIENT SAW THE PO
IT WAS NOTED, THE STIMULATOR WAS EMPTY. IT WAS REPORTED, THE PATIENT COULD ONLY GET FULL COUPLING WHEN LEAN
NOTED, THE PATIENT WAS ELDERLY AND RECHARGING WAS TOO DIFFICULT FOR THE PATIENT. IT WAS REPORTED, THE LONGEV
FREQUENCY MATCHED THE PATIENT�S SETTINGS. HOWEVER, IT WAS NOTED THAT THE PATIENT WAS ELDERLY AND A RECHAR
WAS AN IMPEDANCE CHECK AND EVERYTHING WAS GOOD. REPROGRAMMING WAS NOT NECESSARY BECAUSE, THE PATIENT W
AND THEY STILL COULD NOT DO AN ADEQUATE JOB. THERE WERE NO MALFUNCTIONS DETECTED �OTHER THAN POSSIBLY US
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2016 THAT AN MRI OF THE SPINE CONFIRMED A PRESENCE OF A LEFT SI
SHOW SIGNS OF LEFT UPPER AND LOWER EXTREMITY WEAKNESS AND SENSORY LOSS CONSISTENT WITH A SPINAL CORD INJU
LEAD, 50CM; MODEL #: SC-2218-70, SERIAL/LOT#: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM; MODEL #: SC-3138-35, SERIAL
FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF TH
RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED. ADDITIONAL INFORMATION WA
PRESENCE OF A LEFT C3-D2 HYPERDENSITY WITH SUSPECTED EPIDURAL HEMATOMA. MRI OF THE SPINAL COLUMN CONFIRM
PERFORMED AN EMERGENCY SPINAL DECOMPRESSION AND EVACUATED THE HEMATOMA. THE PATIENT UNDERWENT A LAM
+ C4 HEMILAMINECTOMY WAS PERFORMED CRANIALLY. THE PHYSICIAN BELIEVES THE EVENT IS PROCEDURE RELATED. THE PA
INFORMATION WAS RECEIVED THAT THE PATIENT CONTINUES TO SHOW SIGNS OF NEUROLOGICAL DEFICIT ON THE LEFT LOWE
AND IS RECOVERING. . A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUC
PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN W
HEMATOMA AT C5 AND T1. THE HEMATOMA WAS REMOVED SURGICALLY AND HAS RESOLVED. THE PATIENT WAS PRESCRIBED
PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATION AND IS RECOVERING. A REPORT WAS RECE
OR COMPLICATIONS. HOWEVER, FIVE AND A HALF HOURS AFTER THE PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER
REMOVED IN ORDER TO PERFORM AND MRI. THE MRI FOUND A HEMATOMA AT C5 AND T1. THE PATIENT ALSO UNDERWENT A
PRESCRIBED CORTICOSTEROIDS. THE PHYSICIAN BELIEVES THE SURGERY WAS SUCCESSFUL AND THAT THE DEVICE NOT CAUSE
WAS RECEIVED THAT DURING A TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUCCESSFULLY AND THE PATIENT WA
HOURS LATER, THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN WAS PERFORMED BUT THERE WAS NOTHI
UNDERWENT A CERVICAL LAMINECTOMY AND CORD DECOMPRESSION. THE HEMATOMA WAS REMOVED SURGICALLY AND HA
CAUSE THE HEMATOMA BUT IS UNSURE. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATIO
IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A TRIAL SYSTEM ONE DAY PRIOR TO REPORT. IT WAS REPORTED THE N
MANUFACTURER REPRESENTATIVE �HOW THEY MIGHT WALK WITH THE STIMULATOR THAT HIGH �. IT WAS NOTED THAT TH
FEEL THEIR LEGS AND ARE HAVING TROUBLE WALKING. IT WAS REPORTED THAT AROUND 3AM THE MORNING OF THE REPORT
FALL. IT WAS NOTED THE PATIENT WAS GOING TO SEE AN HCP ABOUT THE ISSUE. IT WAS FURTHER REPORTED THAT THE PATIE
OF BACK PAIN FROM THE MID BACK DOWN TO THE WAIST LINE THAT STARTED AROUND 2-3AM THAT MORNING. IT WAS NOTE
THERAPY ON AT 9PM WHEN THEY WENT BED AND IT WAS FINE BUT WAS TOO HIGH AT 3AM WHEN THEY TURNED IT OFF. IT W
INFORMATION RECEIVED REPORTED THE PATIENT �S LEADS WERE REMOVED AND AN EPIDURAL HEMATOMA AS EVACUATED.
WHITE/BLUE STYLUS WAS USED INSTEAD OF THE GREEN/BLUE STYLUS TO ALLOW FOR BETTER PASSAGE CONTROL AND OPTIM
PATIENT IS RE-EVALUATED BY THEIR HEALTH CARE PROVIDER (HCP). IT WAS REPORTED THE PATIENT IS STILL IN REHABILITATION
THE DURATION OF THEIR PHYSICAL THERAPY IS UNKNOWN. (B)(4). IT WAS REPORTED THE CAUSE OF THE EVENT WAS UNKNOW
THE PATIENT PRIOR TO OR AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THE PATIENT WAS DOING WELL UNTIL 2-3AM
NO PROBLEMS DURING THE TRIAL. LASTLY, IT WAS REPORTED THE PATIENT IS CURRENTLY RECEIVING PHYSICAL THERAPY AND
INFORMATION RECEIVED REPORTED DURING THE PATIENT'S INITIAL TRIAL IMPLANT THE HEALTH CARE PROVIDER (HCP) COULD
THE PATIENT HAD GREAT COVERAGE BUT NOTED THEIR FEET WERE NUMB. THE PATIENT ALSO HAD PARALYSIS DUE TO A PREVI
LEADS. . CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3555-31, LOT# N452567, IMPLANTED: (B)(6) 2014, PRODUCT TYPE
SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: SCREENING DEVICE. (B)(4).
REPORTED THE PT (B)(6) PRESENTED TO THE ER DUE TO PAIN AT THE IPG SITE. IT WAS DETERMINED THE PT'S IPG WAS ERODIN
IT WAS NOTED THE PT SUFFERS FROM EHLERS DANLOS SYNDROME (EDS). THE SURGEON SUSPECTS THIS COULD BE THE CAUSE
WHEELCHAIR DURING THE DAY DUE TO AN AMPUTATED LEG. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT
I SWITCHED FROM A MEDTRONIC SPINAL CORD STIMULATOR TO A NEVRO HIGH FREQUENCY STIMULATOR. I AM ON COUMAD
WANTED TO KEEP THE MEDTRONIC WHICH I FOUND INEFFECTIVE. I HAVE CRPS AND A WHEELCHAIR USER WHO CAN CRUTCH
SET IN AND WAS READMITTED ON EMERGENCY BASIS. THE SECOND OPERATION WAS MORE SUCCESSFUL BUT MY MAIN CONC
TO LIMIT SITTING. I WAS NEVER ADVISED, BY ANY SOURCE, THAT I WOULD NOT BE ABLE TO MOBILIZE IN A WHEELCHAIR OR T
CRUTCHING WILL BE VIRTUALLY IMPOSSIBLE. THIS IS A VERY SERIOUS OVERSIGHT AND MUST BE ADDRESSED URGENTLY. THE M
RECHARGING FOR 2.5 HOURS EVERY 36 HOURS. THE CONTROLLER IS EXPENSIVE TO REPLACE, IS CHEAP PLASTIC AND HAS NO P
IT WAS REPORTED THAT SINCE IMPLANT A PATIENT FELT PAIN WHEN HE STARTED TO WALK. IT WAS STATED THAT IT DIDN �T M
WALK AND HAD TO USE A WHEELCHAIR. IT WAS STATED THAT STIMULATION WAS HURTING HIS BACK BAD. IT WAS REPORTED
THAT AND HE JUST WENT HOME AND LAY DOWN. THE PATIENT STATED, HE WAS FEELING OKAY TODAY BUT HE HASN'T WALKE
GET IN SOONER FOR REPROGRAMMING. PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD
PATIENT WAS SEEN IN OFFICE ON (B)(6) 2014. IT WAS STATED THAT PER THE PROGRESS NOTE IN CHART, THE PATIENT OFFERED
THAT THE PATIENT WAS TO FOLLOW-UP WITH A MANUFACTURER �S REPRESENTATIVE FOR PROGRAMMING. ADDITIONAL INF
UPDATE LATER TODAY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN IN MAY AFTER THE REP
REPROGRAMMED
NONE HAD WORKED AND WAS
OUT. EDUCATED
THE ON STIMULATION.
PATIENT WAS RESISTANT TO IT WAS STATED
MEETING THAT
DUE TO % COST
THE PAIN RELIEF WAS NOT NOTED
OF TRANSPORTATION. AT THE
LATER ONTIME
(B)(6
UNSURE OF THE EXACT NATURE OF THE PATIENT �S COMPLAINT AS HE WOULD NOT MEET TO DETERMINE THE NATURE OF H
REPRESENTATIVE HAD MADE SEVERAL AT TEMPTS TO DISCUSS THE COMPLAINTS WITH THE PATIENT AS HAD THREE OTHER ME
ATTEMPTS TO CONTACT HIM FROM OTHER TEAM MEMBERS. � THE MANUFACTURER RE PRESENTATIVE WAS UNSURE IF THE P
FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP
THE PATIENT NOTED THAT THERE �STIMULATOR WAS NOT WORKING. � THE PATIENT WAS ASKED IF THE PATIENT PROGRAMM
HAVING PROBLEMS WITH THE PATIENT PROGRAMMER AND RECHARGER. THE PATIENT STATED THAT THEY BOTH WERE �DOIN
PATIENT THROUGH SYNCING WITH THE INS BUT THE PATIENT WAS SEEING THE INS BATTERY LOW SCREEN AND THAT THE PATIE
THE RECHARGER. THE PATIENT STATED THAT THEY KNEW THAT NEEDED TO RECHARGE THE INS BUT THE RECHARGER WAS NOT
PROGRAMMER. THE PATIENT NOTED THEY WERE SEEING �THAT SCREEN � ON THE RECHARGER. THE PATIENT ALSO MENTIO
CLARIFICATION AND THE PATIENT WAS SPEAKING IN REGARDS TO USING THE RECHARGER TO TURN STIMULATION ON OR OFF.
THE PATIENT STATED THAT THE LAST TIME THEY HAD SUCCESSFULLY RECHARGED THE INS WAS �SEVERAL WEEKS. � THE PATI
STATED THAT THEY WERE FEELING STIMULATION �UP UNTIL A COUPLE DAYS � PRIOR TO REPORT WHEN THE STIMULATION S
SESSION AND THE PATIENT WAS SEEING THE NORMAL RECHARGING SCREEN WITH COUPLING BOXES BUT NONE OF THE BOXE
COUPLING BOXES BUT THAT WAS NOT SUCCESSFUL. THE PATIENT STATED THAT THEY HAD BEEN TRYING FOR TWO OR THREE H
PATIENT STARTED OUT AT 42 AND AT ONE POINT REACHED 64 AND 76 BUT THE ANTENNA LOCATE FEATURE DID NOT ASSIST PA
AND THE MANUFACTURER REPRESENTATIVE WOULD NOT COME TO THEIR HOME. IT WAS REVIEWED WITH THE PATIENT THAT
REPRESENTATIVE ABOUT RECHARGING AND IF THE PATIENT SHOULD EXPECT ANY PROBLEMS AND THE MANUFACTURER REPR
WHEN THEY DISCUSSED IT WITH THE MANUFACTURER REPRESENTATIVE AND THE PATIENT STATED �THEY HAD ONLY HAD IT S
DID NOT USE IT ALL THE TIME� BUT �THAT WAS WHEN THEY ASKED THE [MANUFACTURER REPRESENTATIVE] ABOUT RECHA
PATIENT REPLIED THAT THIS WAS THE FIRST TIME THAT THEY HAD PROBLEMS WITH COUPLING BOXES AND RECHARGING. THE
STATED THAT THEY WERE AT THE OFFICE OF THE HEALTHCARE PROFESSIONAL (HCP) AND THEY DID NOT SEE THE MANUFACTU
DEVICE CHECK AND/OR PROGRAMMING. IT WAS NOTED THAT THE PATIENT �S RECHARGING ISSUES WERE NOT SUCCESSFULL
PATIENT FOR DIFFICULTY CHARGING THE DEVICE. IT WAS NOTED THAT WHEN THE MANUFACTURER REPRESENTATIVE INITIALLY
PLUGGED THE RECHARGER TO THE WALL AND �ALL SIGNAL WERE LOST. � THE MANUFACTURER REPRESENTATIVE THEN NOT
ISSUES WITH CHARGING FOR THE �PAST WEEK. � IT WAS NOTED THAT THE PATIENT WAS IN A WHEELCHAIR AND REFUSED T
THE PATIENT�S RECHARGER AND THE HIGHEST THEY OBSERVED WAS 46 WITH NO COUPLING BARS. THEN IT WAS NOTED THA
COUPLING BARS. IT WAS FURTHER REPORTED THAT THE RECHARGER WOULD NOT CHARGE THE INS. THE ANOMALY APPEARED
WAS ATTRIBUTED TO THE RECHARGER. IN THE SECTION WHICH BEGINS �IF THE EVENT WAS ATTRIBUTED THE INS WHAT WAS
NOTED THAT INTERVENTIONS INCLUDED PROGRAMMING AND THAT THE RECHARGER WAS REPLACED ON (B)(6) 2014. ANALYS
CHARGING INS OR RECHARGER OR COMMUNICATIONS. IT WAS LATER REPORTED THE PATIENT HAD YET TO RECEIVE THEIR REP
IT WAS REPORTED TURNING THE DIAL DID NOT RESOLVE THE ISSUE. IT WAS FURTHER NOTED THAT WHEN THEY PLUGGED IN T
THE PATIENT WOULD GET ALL THE COUPLING BOXES AND THEN LOOSE THEN THE NEXT MINUTE. THE PATIENT STATED THAT TH
THEY COULD GET THE COUPLING BOXES. IT WAS NOTED THAT WHILE DOING THE ANTENNA LOCATE FEATURE THE TOP ROW N
NOTED THAT THE RECHARGER ANTENNA WAS DAMAGED. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED A NEW ANTE
THERE WERE NO FALLS OR TRAUMA REPORTED. IT WAS REVIEWED WITH THE CALLER THAT THEY MAY NEED TO HAVE THE DEV
NOTED THAT THE PATIENT WAS UPSET FOR THE ISSUES THAT THEY HAD WITH THE RECHARGER. THE PATIENT WAS UPSET AND
OF THIS REPORT. IT WAS LATER REPORTED THAT ANALYSIS OF THE DESKTOP CHARGER FOUND THAT THERE WAS NO ANOMALY
CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU
COUPLE OF THREE WEEKS AGO.� IT WAS NOTED THAT THE PROGRAM THAT THE PATIENT WAS GIVEN WAS NOT A GOOD PRO
TRIAL ON (B)(6) 2014. IT WAS NOTED THAT THE DOCTOR DID NOT GET ONE OF THE WIRES IN THE RIGHT PLACE. IT WAS NOTED
DOUBLED OVER AND SCREAMED AND TOLD THEM TO STOP. IT WAS NOTED THAT IT HAPPENED A SECOND TIME. IT WAS NOTE
THERE. IT WAS NOTED THAT THE PATIENT WAS GOING TO BE IMPLANTED WITH A PERMANENT IMPLANT ON (B)(6) 2014. IT WA
SHOWED THE LEAD WAS PLACED ABOVE THE SPINAL PROCESS. IT WAS NOTED THAT WAS THE LEFT LEAD. IT WAS NOTED THAT
WAS AT (B)(6), KNOW HOW FAR TO WALK BEFORE THE PATIENT HAD TO STOP AND REST BECAUSE OF THE PAIN. IT WAS NOTED
POINT THE PAIN GOT SO INTENSE THE PATIENT TURNED THE UNIT UP AS HIGH AS SHE COULD STAND IT. IT WAS NOTED THAT D
NOTED THAT IT MADE THE PATIENT�S ANKLE WANT TO TWIST MEDIALLY SO THE PATIENT FELT SHE WAS WALKING ON THE OU
THAT THERE WAS TERRIBLE PAIN AROUND HER RIB CAGE. IT WAS NOTED THAT THIS WAS WAY PAST THE SECURITY GATES. ADD
PLACED ON THE SPINOUS PROCESS. IT WAS NOTED THAT THE DOCTOR KNEW THAT IT WAS PLACED IMPROPERLY BECAUSE IT W
A REPORT WAS RECEIVED THAT THE PATIENT �S SCS IMPLANT WAS CAUSING PAIN. THE PHYSICIAN DETERMINED THAT THE IP
CAUSED THE PATIENT TEMPORARY PARALYSIS TO THE LEFT ARM WHEN TURNED ON CAUSING NUMBNESS, SHARP PAIN TO THE
THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-70, SERIAL #: (B)(4), DESCRI
OF THE POCKET SITE. THE PATIENT REPORTED THAT HE FELT HIS ARM WAS PARALYZED WHILE HE HAD THE PERMANENT IMPLA
RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
IT WAS REPORTED THE PATIENT WANTED MORE STIMULATION ON THE RIGHT SIDE THAN THE LEFT SIDE AS HE HAD MORE PAI
RIGHT SIDE, IT ONLY MADE HIS LEG VIBRATE MORE. THE IMPLANT SITE ON THE RIGHT SIDE ALWAYS HURT. HOWEVER, THE PAT
MADE HIM WALK LEANED, LIKE A �HUNCH BACK� AND 99.9% OF THE TIME THE PATIENT WAS IN A WHEELCHAIR AS A RESU
PATIENT COULDN�T GET COMFORTABLE. THE PATIENT WAS PUT ON VICODIN AFTER THE IMPLANT, BUT THAT DIDN �T HELP
ALSO STATED HE WAS GIVEN A SHOT TO SOFTEN THE TISSUE IN THE AREA 2 WEEKS PRIOR TO THE REPORT BUT THAT MADE TH
REPRESENTATIVE WAS PRESENT FOR THE (B)(6) 2014 APPOINTMENT. THERE WERE NO ISSUES WITH THE STIMULATION SYSTEM
SITE WAS NOT AFFECTED BY STIMULATION. THE PATIENT KNEW THE STIMULATION COULDN �T FIX THIS ISSUE. THERAPY WAS
NEUROSTIMULATOR. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 977A260, SE
SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), PRODUCT TYPE: LEAD. P
(B)(4). IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SPINAL CORD STIMULATOR. THE DEVICE GAVE THEM GR
ALLERGIC REACTION AND CONSEQUENT INFECTION AND HAD TO HAVE THEIR DEVICE REMOVED. THE PATIENT WAS IN CONSTA
KARAT GOLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
PAIN, AND ALLOWED THEM TO GET OUT OF THEIR WHEELCHAIR. HOWEVER, THE PATIENT EXPERIENCED A SEVERE ALLERGIC R
WHEELCHAIR AT THE TIME OF THE REPORT. THE PATIENT WANTED TO KNOW IF AN IMPLANT COULD BE MADE OUT OF (B)(6) T
INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. THIS EVENT WAS THE SECOND TIME THE PATIENT HAD AN A
EVENT. . IT WAS FURTHER REPORTED THAT THE PATIENT �S FRIEND GAVE THE PATIENT �S MOTHER SOME MANUFACTURER R
PROVIDE THE NAME OF THE PATIENT.
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PUT RIGHT ON THE PATIENT'S BELT LINE, AND THAT
HIS SPINE AND ACROSS HIS SHOULDER, THAT IT PREVENTED HIM FROM SLEEPING COMFORTABLY, AND THAT THE LEAD WAS A
ISSUES STARTED AT IMPLANT. THE STIMULATION CAUSED HIM TO BLACK OUT IF HE TURNED HIS HEAD TO THE LEFT OR BENT D
IMPLANTED. HE MIGHT NEED TO BE IN A WHEELCHAIR BECAUSE OF THIS. HE ALSO GOT MIGRAINES. THE PATIENT HAD A PERM
IT WAS LATER REPORTED THAT STARTING 6 MONTHS AFTER THE IMPLANT, WHEN HE WORE A BELT AND BENT OVER, HIS LEGS
IF HE TRIED TO RIDE A LAWN MOWER OR A MOTORCYCLE, HIS LEGS WOULDN'T WORK TO STOP IT. IT WAS STATED THAT IT WA
AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED PRODUCT ID 74
PRODUCT TYPE LEAD PRODUCT ID 7495-66, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID
A REPORT WAS RECEIVED THAT THE PATIENT'S PADDLE LEAD WAS EXPLANTED DUE TO 2 DAMAGED CONTACTS. IMAGING WAS
PADDLE LEAD, THE PHYSICIAN SAW 1 CONTACT THAT WAS DISLODGED AND 1 CONTACT WAS MISSING AND REMOVED THE LEA
SUCH AS PAIN AND HEMIPLEGIA. THE NEW LEAD WAS REMOVED AGAIN, THERE WERE NO SIGNS OF HEMATOMA. THE PATIENT
THE PHYSICIAN BELIEVES THE PATIENT IS DOING WELL. A REPORT WAS RECEIVED THAT THE PATIENT'S PADDLE LEAD WAS EXPL
PADDLE LEAD. DURING A REVISION TO REPOSITION, THE SAME PADDLE LEAD, THE PHYSICIAN SAW 1 CONTACT THAT WAS DISL
BROUGHT BACK TO THE OR DUE TO DURAL COMPRESSION SIGNS SUCH AS PAIN AND HEMIPLEGIA. THE NEW LEAD WAS REMO
UNKNOWN IF THE MISSING CONTACT WAS REMOVED FROM PATIENT. THE PHYSICIAN BELIEVES THE PATIENT IS DOING WELL. A
THE CONTACTS AS DISPLACED BUT HAD NOT POPPED OFF THE PADDLE LEAD. DURING A REVISION TO REPOSITION THE SAME P
USED AND WAS REPOSITIONED BUT THE PATIENT HAD TO BE BROUGHT BACK TO THE OPERATING ROOM DUE TO DURAL COM
KEPT IN THE ICU DUE TO TEMPORARY PARALYSIS (NOT DEVICE RELATED). IT IS UNKNOWN IF THE MISSING CONTACT WAS REM
PHOTOGRAPHIC TESTS PERFORMED. THE EXPLANTED PADDLE LEAD EXHIBITED SUBSTANTIAL DAMAGES. THE PROXIMAL ENDS
NOT RETURNED. THE DAMAGE WAS CONSIDERED AS EXPLANT DAMAGE AND IT IS NOT CONSIDERED A DEVICE FAILURE. ADDIT
CONTACT/ELECTRODE WAS REMOVED FROM THE PATIENT, AND THAT THE COMPRESSION SIGNS (PAIN AND HEMIPLEGIA), AND
NOT EXPERIENCE DURAL COMPRESSION SYMPTOMS. THE PATIENT HAD SYMPTOMS SIMILAR TO ONE OF A PATIENT WHO WOU
WAS NOT DEVICE RELATED.
OF NOTE: THE PATIENT REPORTEDLY EXPIRED (B)(6) 2014 IN THE HOSPITAL FROM HIS EXISTING HEART CONDITION. HE SUFFER
WAS NOTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. IT WAS NOTED THAT AN EXPLANT WAS REQUIRED AS A RESULT O
THAT THE PATIENT COMPLAINED OF A LOSS OF SENSATION POST-OPERATIVELY. IT WAS NOTED THAT THE HEALTH CARE PROFES
THORACIC LEVEL WHERE THE LEAD WAS PLACE. IT WAS NOTED THAT THE PATIENT HAD A LOSS OF SENSATION IN THE LEGS AN
NOTED THAT THE PATIENT HAD A LOSS OF REFLEXES OF THE LOWER EXTREMITIES, PARALYSIS, AND WEAKNESS. . CONCOMITAN
SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)
NOT SURE IF IT WAS CORD COMPRESSION. IT WAS NOTED WHEN HE REMOVED THE LEAD THERE WAS NO SWELLING OR HEMA
AND MOVEMENT WAS REPORTEDLY "FINE."
2014, THE PATIENT WAS IMPLANTED WITH A PERMANENT SCS SYSTEM. POST-OP, THE PATIENT EXPERIENCED WEAKNESS AND
VIA THERAPY.
SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE R
HAS BEEN EXPERIENCING RIGHT LEG PARALYSIS/WEAKNESS WHICH BEGAN IN EITHER (B)(6). IT WAS ALSO REPORTED THE PT H
SURGICAL INTERVENTION WILL BE TAKEN AT LATER DATE TO ADDRESS THE ISSUE.
IT WAS REPORTED THAT PATIENT'S CONDITION WAS DECLINING QUICKLY AND THE REPORTER FELT IT HAD SOMETHING TO DO
WEAK AND THE HEALTH CARE PROFESSIONAL (HCP) SAID SHE WAS FINE. THE PATIENT HAD SURGERY AND THEY KEPT HER OVE
TRANSPORTED TO A REHAB FACILITY FOR A COUPLE OF WEEKS. AT CHRISTMAS TIME THE PATIENT HAD A LIVE IN NURSE THERE
SHE COULDN'T WALK OR STAND AND COULDN'T MAKE HER FEET MOVE. THE PATIENT COULD MOVE HER FEET WHEN SHE SAT,
SQUATTING POSITION." THE REPORTER WAS UNCERTAIN IF THE PATIENT HAD TRIED TURNING THE STIMULATION OFF TO SEE I
PATIENT WAS EVALUATED FOR THIS. HOWEVER, THE REPORTER STATED IT WASN'T PARKINSON'S. IT WAS ALSO REPORTED THAT
THESE TESTS WERE DONE IN THE LAST 3 WEEKS. THE PATIENT HAD AN APPOINTMENT WITH HER DOCTOR ON (B)(6) 2014. AT T
WAS WORKING FINE, SHE HAD NO ISSUES WITH THE THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS N
ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PROD
TYPE: PROGRAMMER, PATIENT. (B)(4). (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTAT
OVERDISCHARGE WAS 2015 (B)(6). ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER AND A MANUFACTURER REP
MONTHS. THEY THOUGHT IT WAS ALZHEIMER'S AND THEN DEMENTIA. THE DEMENTIA HAD BEEN REDUCED. SINCE THE PATIE
WITH A MANUFACTURER REPRESENTATIVE AND THEY DID SOMETHING ON THEIR BACK WHERE THEY WAITED AN HOUR. IT WA
(INS) DIDN'T RESPOND. THE DEVICE WAS UNABLE TO BE RECOVERED. THE DOCTOR TOLD THE PATIENT THAT THEY WOULD HAV
IMPLANT AND WAS OUT OF IT FOR ALMOST A YEAR. ON (B)(6) 2013 THE PATIENT WENT HOME FROM THE IMPLANT AND WA
WERE ADMITTED TO THE HOSPITAL FOR MAJOR CONFUSION, SADNESS, AND SHORTNESS OF BREATH. THEY STAYED AT THE HO
WAS FOUND THAT THE PATIENT HAD 50% IMPAIRMENT GETTING FROM CHAIR TO BED, 25% IMPAIRMENT WALKING, 25% ABIL
FROM REHAB ON (B)(6) 2013. ON (B)(6) 2014 THE PATIENT COULD NO LONGER WALK OR STAND. FROM (B)(6) 2014 TO (B)(6)
AND WAS NOTED TO HAVE ADVANCED STAGES OF DEMENTIA. BETWEEN (B)(6) THEY TOOK THE PATIENT OFF ALL MEDICATION
STARTED TO GET A BIT MORE MOBILE AT THIS POINT AND THEIR DEMENTIA WAS ALMOST GONE. THE PATIENT HAD BEEN IN A
(B)(6) 2014 AND THEN DIDN'T TRY. .
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE SPINAL CORD STIMULATOR (SCS) IMPLANTS EXP
REPRESENTATIVE WAS AWARE OF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD WAS EXPLANTED SHORTLY
(B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABL
39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNO
NEUROLOGICAL DEFICITS. IT WAS REPORTED THAT UPON WAKING, THE PATIENT HAD BILATERAL LEG WEAKNESS AND NUMBN
DIAGNOSTIC TESTING WAS PERFORMED, AND THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS STATED THAT THE PAT
HOSPITALIZATION AND MEDICAL INTERVENTION AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED
SURGERY HE EXPERIENCED PARALYSIS IN HIS LOWER EXTREMITIES AND PROPRIOCEPTIVE DEFECTS. ESSENTIALLY HE LOST FUN
COMPLETELY INDEPENDENT IN ACTIVITIES OF DAILY LIVING. THE MANUFACTURER �S REPRESENTATIVE (REP) WAS PROMPTLY
2014.
THE PATIENT GOT CLOSE TO A RFID READER AND IT SEEMED TO SHUT DOWN THE PATIENT �S MACHINE IN THE STORE. WHEN
AREA AND DOES NOT HAVE A DOCTOR YET. IT WAS NOTED THAT THE PATIENT HAS BEEN IN A POWER WHEELCHAIR FOR TEN Y
FUSED, HIS HEADACHES NEVER LET UP. THE PATIENT WAS PUT IN A CHAIR WITH SUSPENSIONS, SO IT WOULD INTERCEPT THE S
PATIENT PROGRAMMER (PP). THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION, THE DEVICE WAS POWERED OFF. SYNCHI
SCREENS WAS POSSIBLE. PROGRAM 1 WAS AT 1.45V AND PROGRAM 2 AT 0.90V, RATE 15. THE PATIENT DECREASED ALL SETTIN
GROUP ADJUST, THE REPORTED ISSUE WAS RESOLVED. THE PATIENT JUST MAKES SURE THAT THE DEVICE IS ON VS. OFF AND LE
THROUGH THE ROOF. THE PATIENT PROGRAMMER MANUAL WAS GOING TO BE MAILED OUT TO THE PATIENT. ADDITIONAL IN
IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYP
CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)
3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLA
WHEELCHAIR AND DRYING HER FOOT ON THE SHOWER LEDGE. THE PATIENT FELT HER STIMULATOR HAD SLIPPED AND WAS ST
MOVE HER LEG. THE PATIENT COULDN�T SIT UP BECAUSE THE PAIN WAS SO BAD. THE PAINT WAS ON THE RIGHT SIDE WHER
STOMACH AND DOWN HER KNEES. THE PATIENT HAD NOT SLEPT MORE THAN 3 HOURS IN 3 DAYS. THE PATIENT WAS REDIREC
PHYSICIAN, BUT THERE WERE WEATHER AND TRANSPORTATION ISSUES. ADDITIONAL INFORMATION WAS REQUESTED, IF RECE
THE PT HAS 2 CERVICAL SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATIO
ISSUE WITH REPROGRAMMING. SUBSEQUENTLY, THE LEAD WAS REPOSITIONED. IT WAS ALSO REPORTED DURING THE SURGIC
NEUROMONITORING IDENTIFIED THE PT HAD DEVELOPED A LEFT SIDE MOTOR DEFICIT. THE PROCEDURE WAS COMPLETED AN
REMAINED IN THE INTENSIVE CARE UNIT OVERNIGHT). ADD'L INFO IDENTIFIED AN SJM REP WAS UNABLE TO ACHIEVE LEFT SID
AS OF 02/05/2014, THE PT IS "DOING WELL", RECEIVING BILATERAL STIMULATION, AND THE WEAKNESS/PARALYSIS HAS RESOL
TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING AND HAD IRRITATING AND IT
CLARIFY, THE PATIENT STATED THE ONLY REASON THEY DIDN'T HAVE BACK SURGERY WAS BECAUSE OF THE STIM DEVICE, AND
RETURNING THEIR CALLS AFTER IMPLANT, AND THAT THEY DID NOT HAVE ANYONE AFTER THEIR IMPLANTING SURGEON LEFT
CAPACITY DUE TO OVERDISCHARGE. (B)(4). . CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODU
(B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTE
THAT THE PATIENT HAD 1 SURGERY FOR THE TRIAL, 1 FOR IMPLANT, AND 1 FOR REMOVAL, AND WOULD HAVE TO HAVE ANOT
PATIENT REPORTED PAIN AND SUFFERING. THE PATIENT REPORTED HAVING THE INS OUT IN (B)(6) 2014 BECAUSE THE INS WAS
MONTHS AFTER IMPLANT. THEN THE PATIENT HAD BURNING AND IRRITATION THAT DID NOT GO AWAY. THE PATIENT TRIED ME
PATIENT WAS NOT SURE IF THE LEADS HAD MOVED OR IF THEY WERE IMPLANTED THAT WAY. THE PATIENT STATED THAT THIS H
REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIE
IT WAS NOTED THAT THE IMPLANT WAS REMOVED ON (B)(6) 2014 BUT THE LEAD WIRE WAS LEFT IN PLACE AS IT COULD NOT
HEALTH CARE PROFESSIONAL TO DISCUSS THE STATUS OF THE LEAD WIRE. ADDITIONAL INFORMATION RECEIVED REPORTED T
MANUFACTURER�S FIELD ACTION. IT WAS NOTED THAT THE PATIENT HAD BEEN TO 3 OTHER HCPS WANTING AN EXPLANT. IT
UNDER RECALL AND WASN�T WORKING RIGHT. THE DEVICE WASN �T CHARGING RIGHT AND THE PATIENT WAS UNABLE TO
REPORTED THAT THE PATIENT�S STIMULATION WAS GOING ON AND OFF BY ITSELF AND INCREASED �REALLY BAD. � THIS H
THEN STOP. THE PATIENT REPORTEDLY TRIED CHARGING AND WAS UNSUCCESSFUL, BUT THEN A COUPLE DAYS LATER STIM WO
A COUPLE OF MONTHS. THE PATIENT HAD SEVERE BACK PAIN, ONSET 3-4 MONTHS AGO. IT WAS NOTED THAT THE DEVICE WA
PATIENT HER KIDNEYS WEREN�T IMPROVING. NO FALLS OR TRAUMA REPORTED. IT WAS LATER REPORTED THE MANUFACTU
HAVING ISSUES WITH HER DEVICE. THE REP CONTACTED THE PATIENT TO OFFER ASSISTANCE, THE PATIENT STATED SHE WAS �
WANT TO MEET WITH THE REP, AND THAT SHE WAS UNDER THE CARE OF A PHYSICIAN. THE PATIENT STATED SHE WAS WORKIN
PHYSICIAN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURING REPRESENTATIVE SAW THE PATIENT
THE LEAD THAT WAS STILL IMPLANTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS USED WITHIN THE PATIENT AND T
LOT OF QUESTIONS REGARDING EXPLANTING HER LEADS.
IT WAS REPORTED, THE PATIENT�S �IMPLANTABLE NEUROSTIMULATOR (INS) EXPLODED IN THE PATIENT �S BACK IN 2013 (B
BOUND BY 2012 (B)(6). IT WAS STATED, THE PATIENT WAS STILL USING THE INS UP UNTIL THE BATTERY EXPLODED. IT WAS NOT
SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. PRODUCT ID 3708140, SERIAL# (B)(4), IMP
37743, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-30, SERIAL# (B)(4
THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INF
UNKNOWN, PRODUCT TYPE: LEAD. (B)(4). GIBERSON, C.E., BARBOSA, J., BROOKS, E.S., MCGLOTHLEN, G.L., GRIGSBY, E.J., KOHU
REPORTS. REG ANESTH PAIN MED 2014;39(1):73 �77. DOI: 10.1097/AAP.0000000000000026 SUMMARY: WE REPORT 2 CASES
POSSIBLE ETIOLOGIES OF THESE COMPLICATIONS. TWO PATIENTS DEVELOPED SPINAL EPIDURAL HEMATOMAS SHORTLY AFTER
REPORTED TAKING ASPIRIN THE MORNING THAT HIS LEADS WERE PULLED, WHEREAS PATIENT 2 HAD NOT TAKEN ASPIRIN IN T
DID NOT FULLY RECOVER FROM THE INJURY TO HIS SPINAL CORD. PATIENT 2 UNDERWENT SURGERY IMMEDIATELY WITH COM
ANESTHESIA AND PAIN MEDICINE GUIDELINES, WHICH STATE THAT NONSTEROIDAL ANTI-INFLAMMATORY DRUGS DO NOT SIG
DRUGS BEFORE EPIDURAL OR SPINAL ANESTHESIA. WE SUGGEST THAT THESE GUIDELINES MAY NOT BE APPROPRIATE FOR NE
RECOMMEND DISCONTINUING NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, PARTICULARLY ASPIRIN, BEFORE NEUROMODU
EVENT: ONE (B)(6) MALE PATIENT WITH CHRONIC PAIN OF THE RIGHT LOWER EXTREMITY UNDERWENT A PERCUTANEOUS SPI
PARESTHESIA AND WAS DISCHARGED IN GOOD CONDITION THREE HOURS AFTER THE PROCEDURE. THE REPORTER STATED TH
COMPLAINING OF SEVERE BACK PAIN AND PARAPLEGIA. IT WAS NOTED THAT PHYSICAL EXAMINATION REVEALED NO FOCAL N
WEIGHT-BEARING BY THE END OF THE VISIT. THE PATIENT REPORTEDLY RECEIVED INTRAVENOUS (IV) MORPHINE EN ROUTE AN
THE PATIENT THAT HE PROBABLY HAD AN ANXIETY REACTION. THE REPORTER STATED THAT THE PATIENT HAD A ROUTINE FOLL
CHANGED, THE GENERATOR WAS REPROGRAMMED AND THE PATIENT WAS SCHEDULED TO RETURN THREE DAYS LATER FOR R
PATIENT REPORTED SATISFACTION WITH THE STIMULATION, 50% TO 60% PAIN RELIEF, AND THE ABILITY TO WALK WITHOUT A
THE EXIT SITE WHICH WAS STOPPED WITH LOCAL PRESSURE. THE PATIENT THE REPORTED TAKING EXCEDRIN THAT MORNING D
BACK PAIN FOLLOWED QUICKLY BY PARAPARESIS. THE PATIENT WAS TRANSPORTED EMERGENTLY TO THE LOCAL HOSPITAL TO E
FROM T5 TO L1-2 WITH SPINAL CORD COMPRESSION. THE REPORTER STATED THAT THE PATIENT WAS ADMITTED AND EXAMIN
NORMALIZED RATIO OF LESS THAN 1.0. THE PATIENT REPORTEDLY SHOWED SOME IMPROVEMENT AND WAS RELUCTANT TO H
THE PATIENT THEN AGREED TO A LAMINECTOMY AND HEMATOMA EVACUATION THAT WAS PERFORMED TWO DAYS AFTER AD
THE NEXT FIVE DAYS. THE PATIENT REPORTEDLY HAD PERMANENT WEAKNESS IN THE LEFT LEG. FURTHER INFORMATION HAS B
RECEIVED REPORTED THAT THE PATIENT HAD EXPERIENCED PERSISTENT NEUROLOGICAL DEFICITS.
IT WAS REPORTED THE STIMULATOR WAS BULGING IN THE PATIENT �S BACK AND THE STIMULATOR WAS MOVING AROUND M
WERE ANY EVENT THAT CAUSED THE CHANGE. IT WAS NOTED THE PATIENT HAD FALLEN A COUPLE OF TIMES BUT THEY DID NO
PUT IT IN A TRUNK BUT THEY WERE UNSURE IF THEY WERE INJURED. IT WAS ALSO NOTED THE EVENT OR SYMPTOM OCCURRE
MOVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FO
PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 377
LEAD. (B)(4).
PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(
THAT THE PATIENT�S HCP (HEALTH CARE PROFESSIONAL) WAS �PUTTING ON THE PADDLE LEAD � AND THE HCP WOULD �
THE PADDLE LEAD� THE PATIENT SUDDENLY WENT PARALYZED FROM HER WAIST TO HER TOES. THE PATIENT ALSO EXPERIENC
PATIENT FELT THAT SHE COULD NOT MOVE OR BEND HER LEGS. THE SURGERY WAS ABORTED AND THE PATIENT HAD A TWO-H
ABOUT 10 HOURS AND WAS �TOTALLY REVERSED NOW. � IT WAS INDICATED THAT THE PATIENT WAS GIVEN A STEROID FOR
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT CALLED IN SICK ON HER ORIGINAL SURGERY DATE AND W
NOW SCHEDULED FOR (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT CANCELLED THE SURG
MANUFACTURER'S REPRESENTATIVE WAS "VERY CONCERNED" ABOUT THE PATIENT"S IMPLANTABLE PULSE GENERATOR (IPG)
PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTE
DONE TODAY. THE BATTERY WAS DISCONNECTED FROM THE LEAD AND 40CM EXTENSIONS WERE ATTACHED TO THE LEAD. AN
WAS DONE WITH NO SUCCESS. THE BATTERY WAS OVERDISCHARGED. THE POCKET FOR THE BATTERY WAS MOVED FROM RIG
IN THE HOSPITAL AND A TRICKLE CHARGE WAS GOING TO BE DONE TOMORROW MORNING BEFORE SHE WAS DISCHARGED, A
HER BATTERY LIFE HAS BEEN DEPLETED. THE PATIENT UNDERSTOOD THAT AND WAS VERY EXCITED TO BE ABLE TO USE HER ST
PATIENT "DIDN'T STOP TAKING HER PLAVIX". ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS CHARGING C
TO CHARGE FULLY BEFORE TURNING STIMULATION BACK ON. IT WAS REPORTED HE ALSO HOLD HER TO CALL IF ANYTHING WA
COMMUNICATION/TELEMETRY ISSUES, SPECIFICALLY THAT THEY COULD NOT INTERROGATE TO CHARGE. IT WAS STATED THAT
STATED THAT THE PATIENT WAS HAVING WORK UP FOR SURGICAL RELOCATION OF HER IMPLANTABLE NEUROSTIMULATOR (IN
RESOLVED BUT THAT THE CAUSE OF THE ISSUE HAD NOT BEEN DETERMINED. IT WAS REPORTED THAT THE PATIENT WAS ALIVE
THE PATIENT HAD �JUST NO STIM�. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS OBESE AND IT
WAS STATED THAT THE PATIENT HAD BEEN SCHEDULED TO MEET WITH HER HEALTHCARE PROFESSIONAL TODAY BUT SHE HAD
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED TO MEET (B)(6) WITH HER HCP. IT WAS
TO TRY CHARGING THE SYSTEM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE (B)(6) MEETING HAD BEEN CANC
INFORMATION WOULD BE UPDATED AS IT WAS RECEIVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIEN
AGO THE DEVICE HAS �SHIFTED ITSELF AT AN ANGLE �. IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO �CONNECT
WAS NOTED THAT THE DEVICE WAS �DEEP�. IT WAS NOTED THAT THE PATIENT STATED SHE LAST HAD STIMULATION 3 WEEK
�RIGHT FLANK�. IT WAS NOTED THAT REVISION WAS BEING CONSIDERED IN THE NEXT COUPLE DAYS. ADDITIONAL INFORM
HAPPENED. IT WAS STATED THAT THE PATIENT WEIGHS 350-400 POUNDS AND WAS BOUND TO A WHEELCHAIR. IT WAS REPOR
NOTED THAT PHOTOS OF THE IMPLANT SITE WERE INCLUDED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PAT
WAS CLOSE TO OVERDISCHARGE. IT WAS REPORTED THAT THE PATIENT HAD LAST CHARGED ON (B)(6) FOR MULTIPLE HOURS W
ON THAT DAY AND WAS LIKELY DISCHARGED A FEW DAYS PRIOR. IT WAS STATED THAT THE DEVICE HAD AN ESTIMATED OD OF
THE COMPANY REPRESENTATIVE CONFIRMED ON (B)(6) 2014 THAT THE PATIENT WAS STILL IN REHAB. ACCORDING TO THE NEU
IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). THE COMPANY REPRESENTATIVE CONFIRMED
PARALYZED. THE TREATING NEUROSURGEON DETERMINED THAT THE STIMULATION TRIAL WAS NOT THE CAUSE OF THE PATIE
CLARIFIED THAT THERE WAS ONE LEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS CER
REQUIRED HOSPITALIZATION. IT WAS NOTED THERE WAS INITIAL PARTIAL QUADRIPARESIS BUT UPPER EXTREMITY STRENGTH W
TRIAL WAS PLACED. IT WAS NOTED THAT AN MRI WAS PERFORMED AND NO HEMATOMA WAS FOUND. IT WAS NOTED THAT T
WAS NOTED THAT THE PATIENT HAD A �SENSATION, BUT COULD NOT MOVE. � IT WAS NOTED THAT THE PHYSICIANS WERE
RIGHT SIDE.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMM
IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED IN 1998 AND THE INS NEVER WORKED. IT WAS NOTED THE PATIENT HAD
STATED THE INS DOES NOT WORK AND THE INS HAD DONE DAMAGE TO THEIR BODY AND THEY HAD CHRONIC PAIN. IT WAS N
TRYING FOR YEARS TO GET THE INS TAKEN OUT, BUT THEIR HEALTHCARE PROFESSIONAL (HCP) WOULD NOT DO IT BECAUSE IT
HCP TO TAKE THE INS OUT. THE REPORTER FURTHER STATED THAT WHEN THE NEW HCP SAW THEIR CHART THEY DECLINED TO
AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SUFFERED FROM A POST-OPERATIVE SPINAL CORD INJUR
WAS STATED THAT THE PATIENT HADN'T BEEN SINCE (B)(6), 2004. IT WAS STATED THAT IT WAS UNKNOWN WHETHER THE PAR
NOT YET RECEIVED; THE CALL RECIPIENT STATED SHE WOULD NEED TO PULL THE PATIENT CHART FROM STORAGE. IT WAS REP
USED. IT WAS NOTED THAT THE LEADS HAD ISSUES. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE A
NON-CERVICAL PATENT LEAD FOR A CERVICAL SPINE STIMULATOR. IT WAS STATED THAT THE LEAD WAS TOO BIG. THE PATIENT
ON LAST FEW MONTHS� AND THAT SHE NEEDED AN MRI �BADLY �. THE PATIENT NOTED �MY PARALYSIS� DISLIKED �G
PRODUCTS: PRODUCT ID: 3998, LOT# LB7638, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 748966, SERIAL# (
PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3998, LOT
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT CAME BACK TO THE HEALTHCARE PROFESSIONAL (HCP) O
PATIENT DID NOT HAVE A REVISION IN 2013. IT WAS NOTED THAT THE PATIENT'S ENTIRE SYSTEM WAS REPLACED ON (B)(6) 201
REFERRING TO WHEN SHE MENTIONED THE WIRES BEING PULLED OUT. IT WAS NOTED THAT THE HCP BELIEVED THAT THE PAT
AVAILABLE AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PREVIOUS SYSTEM H
(B)(4). CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4). IT WAS REPOR
ONE MONTH AND IT INSTANTLY HELPED WITH THEIR PAIN FROM REFLEX SYMPATHETIC DYSTROPHY. THE REPORTER STATED TH
NUMEROUS ISSUES WITH THE WIRES PULLING OUT UNTIL THEY HAD A LAMINECTOMY IN 1999. IT WAS NOTED THE PATIENT H
IMPLANTABLE NEUROSTIMULATORS (INS) BURNING OUT IN 6-8 MONTHS. IT WAS NOTED THE PATIENT HAD A RECHARGEABLE
STATED THEY AT ONE TIME MOSTLY USED CRUTCHES, WALKERS, OR AN ELECTRIC WHEELCHAIR. IT WAS NOTED THE PATIENT H
AND CRUTCHES. THE REPORTER STATED THEY HAD STOPPED ALL PAIN MEDICATION. ADDITIONAL INFORMATION WAS REQUES
HAVING LEAD REVISIONS BECAUSE HER LEADS KEPT PULLING OUT UNTIL SHE HAD HER FIRST LAMINECTOMY IN 1998 OR 1999
STIMULATION CHANGED IN MAY 2002. IT WAS NOTED THAT STIMULATION CHANGED AND THEY TOOK AN X-RAY AND THE LEA
DID A WHOLE SYSTEM CHANGE OUT. IT WAS NOTED THAT THE PATIENT GOT A NEW IMPLANTABLE NEUROSTIMULATOR (INS) O
NOTED THAT THE PATIENT WAS MEETING WITH A MANUFACTURING REPRESENTATIVE ON THE DAY AFTER REPORT TO HAVE EV
THIS REPORT. .
A REPORT WAS RECEIVED THAT THE POST IMPLANT PATIENT WENT BACK TO THE HOSPITAL AS SHE WAS PARALYZED FROM HER
THAT THE PATIENT�S VERY HIGH BLOOD PRESSURE POST-OPERATIVELY COULD HAVE CONTRIBUTED TO THE EVENT. THE PHYS
WELL AFTER THE PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-
DISCARDED BY THE MEDICAL FACILITY.
MANUFACTURER'S EVALUATION: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF HEMATOMA COULD N
AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYS
THE PHYSICIAN SUSPECTED A HEMATOMA, AND TOOK THE PATIENT BACK INTO THE OPERATING ROOM ON THE SAME DAY. TH
REPORTED THE PATIENT HAD REGAINED FUNCTION AFTER THE REMOVAL / DECOMPRESSION OF THE HEMATOMA. THE PHYSIC
IT WAS REPORTED THAT THERE WAS A HEMATOMA. THE PATIENT HAD DEVELOPED AN EPIDURAL HEMATOMA. IT WAS NOTED
WAS TURNED ON THE DAY AFTER THE PROCEDURE. IT WAS NOTED THAT IN THE PROCESS OF DISCHARGING THE PATIENT; THE
THAT THE PATIENT HAD NOT BEEN SEEN OR TALKED TO POST-SURGERY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT
SURGERY WHICH INFLICTED DIRECT TRAUMA TO THE PATIENT �S SPINAL CORD. PARALYSIS WAS NOTED ON (B)(6) 2013 POST
PARALYSIS. IT WAS FURTHER NOTED THAT THERE WAS FAILURE IN RELIEVING SPINAL CORD COMPRESSION ON (B)(6) 2013. TH
THE PATIENT�S INJURIES WERE PERMANENT AND THE PATIENT HAD CHRONIC INTRACTABLE PAIN, SPASTICITY, NEUROGENIC B
ANXIETY, AND SEVERE LIMITATION IN THE PATIENT �S ABILITY TO FUNCTION AND CARE FOR HIMSELF. PRODUCT ID 37746, SER
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL AT THE REHAB FACILITY. IT WAS NOTED THAT T
REHAB. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE NURSE DID NOT HAVE A STATUS REPORT ON THE PATIENT.
GO TO A REHAB FACILITY AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT
PRODUCT TYPE: SCREENING DEVICE. (B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO THERAPY WAS INITIATE
SOME STEPS. . ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STARTING TO MOVE THEIR LEGS. THE REPO
TAKEN TO SURGERY FOR MULTI-LEVEL DECOMPRESSION. THE REPORTER STATED THE PATIENT HAD AN UNEVENTFUL TRIAL LEA
THE LEADS WERE REMOVED AND THE PATIENT WAS SENT FOR AN MRI. IT WAS FURTHER NOTED THE MRI SHOWED THE PATIEN
NOTED THE PATIENT HAD A LOSS OF REFLEXES IN THEIR LOWER EXTREMITIES, PAIN, PARALYSIS, AND WEAKNESS AT THE LEAD
THEY STATED THE PATIENT WAS PARALYZED. THE REPORTER STATED THE PATIENT HAD A BLOOD CLOT �AT THE DOOR � AND
INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS REMOVED A DAY AFTER IT WAS IMPLANTED. THE PATIENT REPORTED THAT
TO THE SCS SYSTEM. THE PATIENT STATED IT TOOK HIM SIX MONTHS TO RECOVER FROM THE PARALYSIS. THE PATIENT ALSO ST
IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, LOT# 0206938300, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEA
EXPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS PARAPLEGIC. A
THAT THE OUTCOME WAS RESOLVED WITH SEQUELAE ON (B)(6)2013. THE SEQUELA WAS NOTED AS PARESIS. (B)(4) ADDITION
CURRENT STATE OF THE PATIENT WAS UNKNOWN. . ADDITIONAL INFORMATION REPORTED THE ETIOLOGY WAS THE LEAD/EXT
AND CLARIFIED THAT THE PATIENT NEVER HAD A FULL-SYSTEM IMPLANT. PATIENT SYMPTOMS WERE PAIN AND PARESIA. IT WA
BOTH THE LEAD AND EXTENSION WERE EXPLANTED, THUS THE PATIENT WAS NOT RECEIVING THERAPY, AND IT WAS UNCLEAR
NON-RELATED EVENT, IN WHICH IT IS UNCLEAR WHAT WAS BEING REFERRED TO. IT WAS NOTED THE PATIENT HAD �JUST UN
WAS RECEIVED AND CLARIFIED THAT THE �TRIAL � LEAD AND EXTENSION WERE EXPLANTED. ADDITIONAL INFORMATION RE
ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED
THERAPEUTIC ALTERATION IN THE SURGICAL SITE, AND THAT THE EPIDURAL HEMATOMA WAS DIAGNOSED BY MEANS OF MRI
PARESTHESIA AND PARESIA OF THE RIGHT LOW LIMB. THE PATIENT HAD MEDICAL OR SURGICAL INTERVENTION PERFORMED T
PATIENT�S LEAD/EXTENSION TRACT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS POSSIBLY RELAT
EVENTS THE PATIENT WAS SEEN FOR ON (B)(6) 2013, WAS KIDNEY STONES. IT WAS ALSO REPORTED THE PATIENT WAS RELEAS
TO TREAT THE RESIDUAL PARESIS. IT WAS NOTED SHE WAS EXPECTED TO RECOVER FROM PARESIS WITH PHYSIOTHERAPY. ON (
STABLE AND WAS STILL UNDERGOING PHYSIOTHERAPY. IT WAS LATER REPORTED ON 11/22/2013 THAT THE PATIENT DEVELOPE
STAPHYLOCOCCUS. THE EXTENSION SITE SCAR HAD VISIBLE PUS. DURING DEVICE EXPLANT SURGERY PUS WAS COLLECTED AT
PRESCRIBED ON (B)(6) 2013 AND THEN ON (B)(6) 2013 THE ANTIBIOTICS WERE CHANGED. ADDITIONAL INFORMATION RECEIV
THERAPY. ADDITIONAL INFORMATION RECEIVED JANUARY 6 REPORTED IT WAS BELIEVED THE PATIENT HAD AN APPOINTMENT
BOTH INCISIONS WERE SWABBED. ON (B)(6) 2013, THE PATIENT HAD PAIN AND PARESIS IN RIGHT LEG. ON (B)(6) 2013, THE PAT
PROVIDED. ON (B)(6) 2013, THE PATIENT HAD AN ANTIBIOTIC CHANGE TO AVELOX, 400 MG, AND RIFADINE, 300 MG. THE PATIE
(B)(4). IT WAS REPORTED THAT SOMEONE HAD A �REALLY BAD EXPERIENCE � WITH A MEDTRONIC NEUROSTIMULATOR FOR
AS PAIN. IT WAS NOTED THAT IT STARTED IN HIS ANKLE, BUT GREW TO COVER BOTH LEGS SO HE WAS IN A WHEELCHAIR. IT W
MEDTRONIC NEUROSTIMULATOR. THE TRIAL �WENT WELL AND SEEMED TO REDUCE MUCH OF THE PAIN. � IT WAS REPORTE
SIT IN HIS WHEELCHAIR. THE �ELECTRO-TECH � TRIED MANY THINGS BUT COULD NOT REPEAT THE TRIAL RESULTS. IT WAS N
SITE WAS AND REMAINED A LOCATION OF SOME OF HIS WORST PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEM
CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # V973526, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3
TYPE EXTENSION; PRODUCT ID 3998, LOT # VA021AX, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT #
ON THE MORNING OF THE REPORT UNABLE TO USE HER RIGHT ARM, WHICH WAS FLACCID. IT WAS STATED THAT THE PROBLE
THE FOLLOWING DAY BECAUSE LEAD HAD MIGRATED. IT WAS STATED THAT THE LEAD HAD BEEN PLACED IN AN AREA WHERE T
THE PATIENT WAS GOING INTO SURGERY FOR A FRACTURED FOOT/ANKLE. IT WAS UNKNOWN WHEN THE FRACTURE TOOK PLA
LEAD COULD NOT BE PLACED DUE TO CERVICAL STENOSIS. THE PATIENT REPORTEDLY HAD LIMITED MOVEMENT OF THE ARM,
MANUFACTURING REPRESENTATIVES WERE �NOT IMMEDIATELY AWARE OF. � FOUR DAYS FOLLOWING INITIAL REPORT IT WA
ER. IT WAS REPORTED THAT THE PATIENT SAID SHE FELL DUE TO RIGHT-SIDED WEAKNESS. IT WAS STATED THAT THE PATIENT W
PRODUCT ID 7496-51, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7434A, SERIAL# (B)(4)
THAT THE PATIENT WAS ADJUSTED IN A CHAIR AND THE DEVICE WORKED OKAY WHEN SITTING UP, BUT WHEN LAYING DOWN,
DOCTORS THAT SHE WAS HAVING PAIN AND BURNING IN HER BACK RIGHT WHERE THE LEADS WERE. THE PATIENT HAD AN X-R
STRONG IN HER LEG HAD BEEN GOING ON FOR 10 YEARS. THE PATIENT WANTED SOMEONE TO MAKE THE DEVICE WORK PROP
FOR HER BACK AND LEGS BECAUSE THEY DID NOT HAVE THAT MODEL. THE PATIENT WAS DIRECTED TO CONTACT HER DOCTOR
STIMULATION WAS OKAY WHEN THE PATIENT WAS SITTING UP, BUT TOO STRONG WHEN LYING DOWN. THE PATIENT WAS IN A
MENTIONED THIS TO HER PHYSICIAN, BUT THE PHYSICIAN THOUGHT THE PATIENT WAS MAKING IT UP AND LOOKING FOR PAIN
BURNING BY HER LEADS AND BY THE DEVICE SITE THAT STARTED EIGHT YEARS AGO. THE PATIENT ALSO FELT PAIN WHEN SHE V
WOULD �GO INTO A SPASM� WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF, AND THE PATIENT HAD
AGO WHEN NEW LEADS WERE PUT IN. THE PATIENT �S NERVES IN HER SPINAL COLUMN WERE REPORTED AS DETERIORATING
THAT THE �MACHINE WAS WORKING FINE.� THE PATIENT WAS REPORTED AS HAVING A CT SCAN SCHEDULED FOR THE FOLL
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD BEEN IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2013, AND
PARALYZED BY THE TIME AN AMBULANCE HAD ARRIVED. IT WAS REPORTED THAT THE IMPLANT HAD BEEN REMOVED ON (B)(6
WAS REPORTED TO BE AT A REHAB HOSPITAL WHERE THEY WERE RECEIVING PHYSICAL THERAPY. (B)(4). PRODUCT ID 97740, S
ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS CONFIRMED THE EVENT DATE WAS 2013-(B)(6). ADDITIONAL IN
REPORTED THAT A PATIENT LOST FEELING FROM THE WAIST DOWN AT 5:00 AM THE MORNING OF THE REPORT. IT WAS NOTED
FACILITY TO RECEIVE TREATMENT FOR PARALYSIS. THE CURRENT STATUS OF THE PATIENT WAS LISTED AS ALIVE WITH INJURY A
IT WAS REPORTED THE PATIENT�S IMPLANTABLE NEUROSTIMULATOR (INS) BEGAN �TURNING ITSELF OFF SPORADICALLY �
WOULD SYNC HIS PATIENT PROGRAMMER AND WOULD �FIND THE INS WAS OFF. � IT WAS NOTED THAT THIS OCCURRED BO
NOTICED.� IT WAS NOTED THE PATIENT RECEIVED A COCHLEAR IMPLANT A WEEK PRIOR TO REPORT AND THAT THE �INS ISS
THE PATIENT REPORTED HE WAS STILL HAVING CONCERNS AND HAD NOT SOUGHT FURTHER HELP. A SUPPLEMENTAL REPORT
HAVE A SHORT PHYSICIAN MODE RECHARGE (PMR) DONE. THE OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION A
SHUTTING OFF BY ITSELF; THIS HAD BEEN HAPPENING MORE OFTEN. THE PATIENT STATED IT COULD HAPPEN TO HIM ANYWH
INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. IT WAS FURTHER REPORTED THAT AS OF (
RECHARGER; PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIA
FURTHER STATED THAT THE PATIENT MET WITH A COMPANY REPRESENTATIVE. THE DEVICE WAS STILL PERIODICALLY SHUTTING
TURN IT BACK ON. IT WAS STATED THAT THE PATIENT'S WHEELCHAIR WAS POWERED. ELECTRODE IMPEDANCES SHOWED ELEC
THE PATIENT TO KEEP A LOG OF WHEN THE DEVICE SHUTS OFF. THE SOFTWARE CARD WAS ALSO REQUESTED. THE PATIENTS ST
IF IT RESOLVED THE PROBLEM DUE TO THE FACT THAT IT SHUT OFF AT RANDOM TIMES ACCORDING TO THE PATIENT. THE PATI
BE SENT. IT WAS FURTHER REPORTED THAT THE ISSUE WAS STILL ON-GOING. THERE WAS STILL NO "RHYME OR REASON" TO T
STATED IT COULD GO OFF WHEN HE WAS ASLEEP, AS HE LEFT IT ON 24/7. THE LAST REPORGRAMMING 3-4 MONTHS AGO DID
UPCOMING APPOINTMENT ON (B)(6) 2014 AND REQUESTED A REPRESENTATIVE BE PRESENT; THE PATIENT WAS REDIRECTED B
REPORT WILL BE SENT.
SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEV
5 HOURS AFTER IMPLANT, THE PT EXPERIENCED SYMPTOMS OF PARALYSIS. POST-OPERATIVE SYMPTOMS WERE NORMAL UP U
THE LEAD WAS REMOVED AND THE HEMATOMA EVACUATED. THE MORNING AFTER SURGERY, THE PT COULD NOT MOVE HER
AN INPATIENT REHABILITATION CENTER. THE PT IS UNABLE TO WALK, HOWEVER, SHE CAN STAND WITH ASSISTANCE. THE PT IS
IT WAS REPORTED THAT AN UNSPECIFIED ADVERSE EVENT OCCURRED DURING IMPLANTATION OF A SPINAL CORD STIMULATO
IMPLANTING.� IT WAS STATED THAT AN MRI OF THE HEAD/BRAIN/CERVICAL SPINE AREA WAS TO BE TAKEN. IT WAS STATED �
RECEIVED ABOUT THE ADVERSE EVENT THAT OCCURRED DURING CERVICAL LEAD IMPLANTATION. IT WAS REPORTED THAT THE
BUT THAT THE PATIENT WAS UNABLE TO MOVE HER RIGHT ARM AND RIGHT LEG IMMEDIATELY FOLLOWING THE PROCEDURE.
BEEN PERFORMED BUT IT WAS REPORTED THAT IT WOULD BE PERFORMED IN THE FUTURE, INCLUDING AN MRI. ADDITIONAL
INFORMATION WAS RECEIVED THAT THE BRAIN SCAN AND CERVICAL MRI RESULTS �WERE OK �. IT WAS CONFIRMED THERE
HAD A HISTORY OF STROKES AND THAT THE BRAIN SCAN REVEALED A SMALL STROKE ON THE RIGHT SIDE OF THE BRAIN, BUT
SYMPTOMS WERE PRESENT WITH OR WITHOUT THE STIMULATION ON. IT WAS REPORTED THAT THERE WAS NO INTERVENTIO
HELPED HER WITH HER RIGHT BICEP PAIN, WHICH WAS HER ORIGINAL PAIN �. IT WAS REPORTED THAT THE PATIENT HAD BEE
�HAD FEELING THOUGH� AND THAT SHE FELT STIMULATION FROM THE DEVICE. PRODUCT ID: 977A290, SERIAL# (B)(4), IMP
IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A FUTURE DATE BECAUSE THE PATIENT'S IPG CATCHES O
THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO
CONCOMITANT: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLA
45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRA
CAUSE OF THE EVENT WAS AN MRI. IT WAS NOTED, THE PATIENT HAD NEUROLOGIC DEFICITS TO THEIR LOWER EXTREMITIES. I
THE PATIENT OUTCOME WAS SERIOUS INJURY OR ILLNESS THAT WAS ONGOING. ADDITIONAL INFORMATION RECEIVED REPOR
THAT AT THE END OF (B)(6) 2013 THE PATIENT HAD BEEN GIVEN A WHOLE HEAD MRI IN �THE MIDDLE OF THE NIGHT � WHIL
WHOLE HEAD WAS IN THE MRI. IT WAS NOTED THAT SINCE THE MRI THE PATIENT HAD HAD SEVERAL ISSUES TAKE PLACE. THE
PATIENT WAS HAVING �PROGRAMMING ISSUES.� IT WAS NOTED THAT PATIENT HAD STIMULATION IN THE WRONG LOCATIO
WHEELCHAIR. IT WAS FURTHER NOTED THAT THE PATIENT WOULD BE SEEING THE HEALTHCARE PROFESSIONAL AND MANUFA
AND LEADS WERE INSERTED INTO HIS C1 AND C2 FOR HIS ARMS. IT WAS LATER REPORTED THAT THERE WAS AN OVERSTIMULA
BENEFIT BUT RIGHT SIDE THE PATIENT EXPERIENCED SHOCKING/JOLTING SENSATION EVEN WITH MINIMAL AMPLITUDE. PATIE
EITHER. THE PATIENT WAS IN GOOD SHAPE PRIOR TO THE MRI, WAS RUNNING FOR AN ACTIVITY AND WAS IN A WHEELCHAIR
TO VERTIGO ISSUES HE WAS HAVING. PATIENT HAD STIMULATION SENSATION THROUGH ENTIRE BODY AFTER MRI PERFORME
THE MRI PATIENT HAD PROBLEMS COMMUNICATING WITH THE INS. PATIENT WAS GOING TO GET AN X-RAY FOR LEAD MIGRAT
FINE, NO ISSUES. REPROGRAMMING WAS NOT ABLE TO GET RIGHT ARM LIKE PREVIOUSLY BUT THE LEFT WAS OK. THE PATIENT
REPORTED THE ISSUE WAS STILL GOING ON AND THE REPRESENTATIVE WAS GOING TO SEE THE DOCTOR ON THE DAY OF THIS
RECEIVED AS OF THE DATE OF THIS REPORT.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-3138-35, SERIAL/LOT # (B)(4), DE
DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVIC
THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW
ON BOTH LEGS. THE PATIENT UNDERWENT A LEAD PULL WHERE A HEMATOMA WAS DISCOVERED WHICH WAS ALSO REMOVE
INFORMATION WAS RECEIVED THAT THE PHYSICIAN FEELS THE PARALYSIS WAS PROCEDURE RELATED.
IT WAS ADDITIONALLY REPORTED THAT DR. WORKMAN SAID THAT "THIS WAS NOT SOMETHING HE WAS AWARE OF." IT WAS R
FINE." HE HAD NO INFORMATION TO PROVIDE REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLE
WAS IMPLANTED IN 2002. THE PATIENT STATED THAT IT HAD PARALYZED HER. THE PATIENT STATED THAT SHE HAD HAD TO GO
REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A
PROGRAMMER. PATIENT PRODUCT ID: 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODU
PRODUCT TYPE: LEAD. PRODUCT ID: 3587A, LOT# L93908, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-
TYPE: EXTENSION. PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID:
PRODUCT TYPE: LEAD. PRODUCT ID: 3587A, LOT# L93908, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. (B)(4). .
METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NON
MET ACCEPTANCE CRITERIA. THEREFORE THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUS
LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY
REPORT: 1627487-2013-21146, 21147. IT WAS REPORTED THE PT EXPERIENCED A SUDDEN ONSET OF HIP PAIN WHERE THE IPG
SUBSEQUENTLY, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2013, TO RELOCATE THE IPG SITE WHICH RESOLVED
THE EMERGENCY ROOM DUE TO THE NATURE OF THE DISCHARGE. THE PT RECEIVED INTRA-VENOUS ANTIBIOTICS. SUBSEQUE
REPORTED THE PT WAS TOLD SHE HAD A STAPH INFECTION. FOLLOW-UP IDENTIFIED THE PT'S INFECTION HAS RESOLVED.
DEVICE 1 OF 3. REFERENCE MFR. REPORT: 1627487-2013-21147, 21148. IT WAS REPORTED THE PT EXPERIENCED A SUDDEN O
IPG RUBBING ON THE CHAIR. SUBSEQUENTLY, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2013, TO RELOCATE TH
THE PT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO THE NATURE OF THE DISCHARGE. THE PT RECEIVED INTRA-VENOU
ADDITIONALLY, IT WAS REPORTED THE PT WAS TOLD SHE HAD A (B)(6) INFECTION. FOLLOW-UP IDENTIFIED THE PT'S INFECTION
DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS
REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS
THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NON
ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION:
REPORT: 1627487-2013-21146, 21148. IT WAS REPORTED THE PT EXPERIENCED A SUDDEN ONSET OF HIP PAIN WHERE THE IPG
SUBSEQUENTLY, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2013 TO RELOCATE THE IPG SITE WHICH RESOLVED T
THE EMERGENCY ROOM DUE TO THE NATURE OF THE DISCHARGE. THE PT RECEIVED INTRA-VENOUS ANTIBIOTICS. SUBSEQUE
REPORTED THE PT WAS TOLD SHE HAD A STAPH INFECTION. FOLLOW-UP IDENTIFIED THE PT'S INFECTION HAS RESOLVED.
A REPORT WAS RECEIVED THAT FOLLOWING THE IMPLANT PROCEDURE THE PATIENT WAS UNABLE TO MOVE ALL OF HER EXTR
PATIENT EVENTUALLY REGAINED MOVEMENT ON THE LEFT SIDE OF HER BODY AND WAS BEGINNING TO REGAIN MOVEMENT O
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT �S FUNCTION IS IMPROVING AND THE PATIENT CONTINUES TO
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT
WAS ABLE TO WALK AROUND WITH A CRUTCH AND HAD NOT USED A WHEELCHAIR. PATIENT HAD TO TAKE MORE PAIN KILLER
(INS)/ THERAPY HAD BEEN CUTTING OUT THE WEEK OF THIS REPORT AND THE PATIENT WAS NOT ABLE TO WALK. INS WAS NO
THERAPEUTIC EFFECT. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPOR
A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO PARALYSIS OF HER LOWER EXTREMITY. THE PATIENT'S
PHYSICIAN AND IS COMFORTABLE. .
IT WAS REPORTED THAT THE PATIENT PROGRAMMER WAS NOT TURNING THE STIMULATION OFF FOR ABOUT SIX WEEKS PRIO
PROGRAMMER. THE PATIENT REPORTED THAT �SOMETIME � THE SETTING OR NUMBERS ON THE PATIENT PROGRAMMER SC
DID NOT GIVE AN ACCURATE READING ON �HOW HIGH IT WAS TURN UP TO � AND �NUMBERS OF VOLTS WERE NOT RIGHT
PATIENT NOTED THAT �SOMETIME VIBRATION WAS HIGH AND THE NUMBERS WERE NOT EVEN HIGH. � THE PATIENT OBSER
PROGRAMMER DID NOT SHUT THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF. THE PATIENT NOTED THAT �A FEW MONTH
SORE� BECAUSE IT WAS SO HIGH. THE PATIENT REPORTED THAT IT DID NOT �HOLD � WHEN IT WAS SET AT �250-300 � A
THEY DID NOT HAVE A HEALTHCARE PROFESSIONAL (HCP). IT WAS FURTHER REPORTED THAT THE PROGRAMMER WOULD MA
THAT THE DEVICE WOULD TURN STIMULATION OFF AT RANDOM AND CHANGE SETTINGS AT RANDOM AS WELL. IT WAS NOTE
PATIENT�S KNOWLEDGE. IT WAS FURTHER REPORTED THAT THE DIGITAL BOARD OF THE PATIENT PROGRAMMER WAS CORRO
37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3998, LOT# V012935,
ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).
IT WAS REPORTED THE PATIENT HAD AN EVENT OF MAXIMUM STIMULATION FOLLOWED BY LOST FEELINGS AND STRENGTH IN
CAN'T MOVE LEGS. PATIENT HAS LOST MOBILITY. IT WAS REPORTED THERE WAS AN OVERSTIMULATION SENSATION. PATIENT I
WAS SET WITH AN UPPER VOLTAGE LIMIT OF 3 VOLTS. IT WAS REPORTED THERE WAS AN OVERSTIMULATION AND A SHOCKING
DONE. IT WAS NOTED ONE PROGRAM ON THE PATIENT'S STIMULATOR WAS ON 8.0 VOLTS WHICH WAS NOTES AS "WELL ABOV
CONFIRMED THAT THE PROGRAMMER WAS NOT BEING ACTIVATED. THE PATIENT SUDDENLY RECEIVED A SHOCK WHILE STAND
LEGS. THE PATIENT WAS PROGRAMMED TO A MAXIMUM AMPLITUDE OF 2.0 VOLTS FOR ALL PROGRAMS. THE PATIENT RECEIV
COMPLAINED OF LOSS OF REFLEXES IN LOWER EXTREMITIES ALONG WITH PAIN AND WEAKNESS. CONCOMITANT MEDICAL PRO
PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).
IT WAS REPORTED THAT A TRIAL PATIENT WAS BELIEVED TO HAVE ACUTE PARALYSIS. IT WAS NOTED THAT THE TRIAL OCCURRE
TO BE �DOING GREAT.� IT WAS NOTED THAT THE REPORTER FOUND OUT ON 2013-(B)(6) AND THERE APPEARED TO BE AN E
WAS REPORTED THAT EVERYTHING HAD BEEN PULLED NOW AND THE REPORTER WAS UNSURE WHEN THAT OCCURRED. IT WA
REPORT. (B)(4) PRODUCT ID 3874, LOT# VA0AY6G, IMPLANTED: 2013-(B)(6), (B)(4).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-1110-02 SERIAL # (B)(4), DESCRI
MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS STILL RECOVERING AT HOME AND IS STILL
THE PHYSICIAN BELIEVES THAT THE PARALYSIS WAS PROCEDURE RELATED, DUE TO THE PADDLE PLACEMENT OR PATIENT �S N
NUMBNESS FROM THE WAIST DOWN TO HER KNEES.
THE PT'S PERMANENT PROCEDURE, THE PT WAS HOSPITALIZED DUE TO EXPERIENCING NUMBNESS IN HIS LEGS WHICH CAUSE
CATHETER. AS OF (B)(4) 2013, THE PT'S ISSUES WERE IMPROVING. FOLLOW-UP IDENTIFIED THE PT IS IN A REHABILITATION FAC
STILL EXPERIENCING SOME NUMBNESS. ADDITIONALLY, IT WAS REPORTED THE PT IS RECEIVING EFFECTIVE STIMULATION.
(B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED THAT A SPECIMEN OF "EPIDURAL FIBROTIC MASS AND LEADS" (TWO
THE REPORTED HISTORY OF FIBROSIS SURROUNDING THE LEAD COMPONENT. SPECIFICALLY, DENSE FIBROVASCULAR TISSUE W
ORGANISMS ON THE EXAMINED SECTIONS; HOWEVER, INFECTION COULD NOT BE COMPLETELY EXCLUDED AND "CLINICAL CO
RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS EPIDURAL COMPRESSION FROM INFLAMMATORY MASS ON CERVIC
THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT AND THE PATIENT OUTCOME WAS NOTED AS ONGOING SERIOU
RELATED TO THE STIMULATOR LEADS SITTING OVER TOP OF THE SPINAL CORD.� IT WAS NOTED THAT �IT MADE A BIG FIBRO
WAS LATER REPORTED THAT THERE WAS NO MALFUNCTION OF THE IMPLANTABLE NEUROSTIMULATOR OR CERVICAL EPIDURA
WEAKNESS. SEE ATTACHED USER FACILITY MEDWATCH, USER FACILITY REPORT NUMBER (B)(4). (B)(4) IT WAS REPORTED THAT
NOTED THAT THE SYSTEM WAS EXPLANTED, A CULTURE WAS DONE, THE LEADS WERE SENT TO THE HOSPITAL PATHOLOGY LAB
UNKNOWN WHAT THE CAUSE OF THE PARALYSIS WAS AND IF IT HAD RESOLVED OR WAS ONGOING. ADDITIONAL INFORMATIO
IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N250632, IMPLANTED: (B
PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 355531, LOT#
PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT T
IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT
PRODUCT TYPE: LEAD. (B)(4). IT WAS REPORTED THAT THE PATIENT HAD WOKEN UP ON THE MORNING OF THIS REPORT IN TE
WITH THERAPY ON AND CONFIRMED THAT THERAPY WAS OFF WHEN SHE WOKE UP. THE REPORTER STATED THAT THE PATIEN
DOWN THE RIGHT LEG. IT WAS LATER REPORTED THAT THE FOLLOWING MORNING, STIMULATION WAS BACK TO ZERO AND OF
INITIAL REPORT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND A LOSS OF STIMULATIO
STATED THAT STIMULATION HAD BEEN SHUTTING OFF AT RANDOM TIMES AND RESETTING THE AMPLITUDE OF ALL PROGRAM
HIGH IMPEDANCES OF GREATER THAN 10000 OHMS WERE OBSERVED ON TWO ELECTRODES ONLY WHILE THE PATIENT WAS IN
REPROGRAMMED AND ADAPTIVESTIM WAS ACTIVATED AT THE PATIENT �S APPOINTMENT. THE PATIENT REPORTED THAT STIM
USING STIMULATION FOR THREE DAYS PRIOR TO THE APPOINTMENT. THE PATIENT REPORTED FEELING PAIN ALONG WITH STIM
WAS REPROGRAMMED TO ACHIEVE NEW COVERAGE OF THE BACK THAT HAD NOT BEEN PREVIOUSLY STIMULATED. THE PATIEN
THAT STIMULATION HAD TURNED OFF FOR THE PAST THREE NIGHTS AROUND 9-10PM. THE PATIENT STATED THAT THE POSITIO
ARRIVED AT THE APPOINTMENT IN A WHEELCHAIR �DEMONSTRATING AND VERBALIZING PAIN. � THE PATIENT STATED THAT
DISSATISFACTION WITH THE SYSTEM. IT WAS NOTED THAT AN IMPEDANCE TEST REVEALED NO ABNORMALITIES. THE REPORTE
AND THE RIGHT LEAD WAS DOWN APPROXIMATELY ONE AND QUARTER VERTEBRAL LEVELS. THE REPORTER STATED THAT ADA
STIMULATION WAS THEN TURNED OFF AND THE PATIENT WAS GIVEN CONTROL OF WHEN STIMULATION WAS TURNED ON AN
OF STIMULATION WHEN USING MANUAL MODE. THE PATIENT ONLY EXPERIENCED AN INCREASED FEELING OF STIMULATION W
MONTH AND REPORT ANY INSTANCES OF CONCERN TO THE HEALTH CARE PROVIDER (HCP) AND MANUFACTURING REPRESEN
THE STIMULATOR BATTERY WAS DEPLETED. IT WAS FOUND THAT THE PATIENT PROGRAMMER BATTERIES WERE LOW AND THE
TO MAKE ADJUSTMENTS. THE PATIENT REPORTED THAT THE STIMULATOR WAS STILL SHUTTING OFF ON ITS OWN. THE PATIEN
PATIENT REPORTED AN INCREASED RELIEF OVER THE TRIAL, WHICH WAS 50%. ADDITIONAL INFORMATION HAS BEEN REQUEST
(B)(4). IT WAS REPORTED THAT THE PATIENT HAD A BILATERAL LOWER LEG WEAKNESS. THE INS (IMPLANTABLE NEUROSTIMUL
AFTER SURGERY THE PATIENT BEGAN TO EXPERIENCE BILATERAL LOWER LEG WEAKNESS THAT PROGRESSED TO THE POINT THA
CT SCAN AND BLOOD WORK WITH NEGATIVE RESULTS. SHE WAS DISCHARGED AND WAS SEEN IN HCP'S (HEALTH CARE PROFES
STATED SHE TURNED IT OFF BUT SHE COULD STILL FEEL THE STIMULATION. PATIENT'S INS WAS INTERROGATED AT HCP'S OFFIC
PLACEMENT WAS GOOD AND UNCHANGED FROM IMPLANT. THE PATIENT AND HER HUSBAND ELECTED TO GO BACK TO THE E
WAS LATER SEEN BY THE HCP. SHE CAME INTO THE OFFICE IN A WHEELCHAIR BUT SHE FELT HER STRENGTH WAS SLOWLY IMPR
BACK TO BASE LINE, THE STIMULATION WOULD BE TURNED BACK ON. IF THERE CONTINUED TO BE NO IMPROVEMENT, THE DE
THAN ONE WEEK LATER IT WAS REPORTED THAT SINCE THE STIMULATION WAS OFF, THERE HAD BEEN SOME IMPROVEMENTS
THERE WAS NO FALLS OR TRAUMA PER THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILA
THE PATIENT'S LEG WEAKNESS HAD RESOLVED. NO CAUSE WAS DETERMINED FOR THE WEAKNESS ISSUE. THE PATIENT'S IMPLA
REPORTED AS DOING WELL AND HAD NOT BEEN SEEN SINCE THE LAST VISIT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOL
SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97791, LOT# N394957, IMPLANTED: (B)(6) 2013, PRODU
FOLLOW UP INFORMATION REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT HAD HIGH BLEEDING TIME VAL
NEUROSTIMULATOR DEVICE. THE PATIENT HAD A CT SCAN AND UNDERWENT EMERGENCY SURGERY TO REMOVE THE BLOOD
FOLLOW UP REPORT WILL BE SENT. CONCOMITANT PRODUCTS: PRODUCT ID 387345, LOT# UNKNOWN, IMPLANTED: (B)(6) 201
2013, PRODUCT TYPE SCREENING DEVICE. (B)(4). . IT WAS REPORTED THE PATIENT HAD EMERGENCY SURGERY TO EVACUATE A
SHORTNESS OF BREATH. IT WAS NOTED THE PATIENT FOLLOWED UP WITH THEIR HEALTHCARE PROFESSIONAL (HCP) WHO DIS
PARALYSIS IN THEIR LOWER EXTREMITIES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR FURTHER EVALUATION AND
DIAGNOSTIC TESTING AND PREPARATION FOR SURGERY. IT WAS STATED THE PATIENT HAD ABNORMAL COAGULATION STUDIES
NEUROLOGICAL DEFICITS UPON DISCHARGE FROM THE HOSPITAL.
DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-07236, 07237. IT WAS REPORTED THE PATIENT WAS RECENTLY EXPER
FOR MIGRAINES (OFF-LABEL USE) AND HAD NOT RECEIVED EFFECTIVE STIMULATION. IN ADDITION, THE PATIENT REPORTED A
PATIENT WANTED TO HAVE AN MRI AND WAS REQUESTING FOR THE SCS SYSTEM TO BE REMOVED. RECALL #S: 1627487-07262
IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO
IT WAS REPORTED, THE PATIENT HAD EXCRUCIATING PAIN AND SHARP PAIN RADIATING AROUND THEIR RIBS AND BACK AND D
WAS �AFRAID OF PARALYSIS SETTING IN.� IT WAS LATER REPORTED THAT THEY WERE PLANNING REMOVAL OF THE SYSTEM
IMPLANTABLE NEUROSTIMULATOR WAS REMOVED. PRODUCT ID 37754 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRO
PRODUCT TYPE LEAD. (B)(4).
THE PT REPORTED SHE HAD PARALYSIS FROM THE WAIST DOWN AFTER THE IMPLANT OF HER SYSTEM IN (B)(6) 2011. THE PT R
SPREAD TO BOTH LEGS. A CT SCAN WAS PERFORMED, AND IT WAS REPORTED THE PT HAD BLEEDING ALONG THE SPINE FOR A
STIMULATION WAS TURNED ON 2 WEEKS LATER, BUT WAS UNCOMFORTABLE, SO THE STIMULATION HAD BEEN TURNED OFF S
THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT
PRODUCT ID 39286-65 LOT# SERIAL# (B)(4), IMPLANTED: 2010-10-07 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 37752 LO
REPORTED THAT THE PATIENT�S LEGS �GAVE OUT � IN (B)(6) 2012 AND THEY HAD NO FEELING IN THEIR LEGS. THE PATIENT
�COLLAPSED C3 AND C4� AND THAT WAS WHY THEY COULD NOT FEEL ANYTHING IN THEIR LEGS. THE PATIENT WENT TO TH
REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. . ADDITIONAL INFORMATION RECEIVED REPORTED THAT
AND THEY WERE IN PAIN FROM THE WAIST DOWN. THE REPORTER STATED THAT IN 1999, 2008, AND 2009 THEY HAD SURGERY
SCAN WAS DONE DURING THIS TIME PERIOD. THE REPORTER STATED THEY WENT TO THE EMERGENCY ROOM ON (B)(6) 2013.
IN THEIR NECK IN (B)(6) 2013. IT WAS FURTHER NOTED THE PATIENT HAD BEEN IN AND OUT OF THE HOSPITAL AND REHAB SIN
AFTER THE SURGERY THE HCP TOLD THEM THE SURGERY WAS A SUCCESS, BUT BECAUSE OF SO MUCH NERVE DAMAGE IN THE
PRODUCT ID: 37746, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: NEU_ UNKNOWN_LEAD, LOT
NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4). IT WAS REPORTED THE TRIAL PATIENT RAN OVER THEI
IT WAS STATED AN IN-HOME NURSE HELPED THE PATIENT POSITION THE LEADS BACK INTO THE MLTC BUT THE PROGRAMMER
PROGRAMMER OFF AND BACK ON THE PROGRAMMER DISPLAYED A 006 ERROR. IT WAS LATER REPORTED THE PATIENT ALSO P
BEEN GETTING 100 PERCENT PAIN RELIEF SO THEY WERE GOING TO GET A PERMANENT IMPLANT. REPORTEDLY, THERE WAS N
PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 37742, SERIAL# (B)(4),
EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3777-45,
(4). ADDITIONAL INFORMATION RECEIVED ABOUT 11 MONTHS LATER REPORTED THAT THE PATIENT HAD LOST 200 POUNDS SI
NEVER HAD HER DEVICE CHECKED. IT WAS ALSO NOTED THAT SHE WAS PARALYZED ON HER LEFT SIDE AND SHE HAD ADD DIAG
STIMULATOR. THE PATIENT HAD BEEN SINCE BY MANY NEUROSURGEONS AND THE PARALYSIS WAS MOST LIKELY A RESULT OF
THAT THE PATIENT LOST A LOT OF WEIGHT AND AS A RESULT, COULD FEEL THE IMPLANTABLE NEUROSTIMULATOR (INS) MOVIN
AFTER PUTTING IN NEW BATTERIES INTO THE PROGRAMMER, THE PATIENT GOT A �POOR COMMUNICATION � SCREEN WHI
INCREASED HER ORAL MEDICATIONS BECAUSE SHE HAD NOT BEEN ABLE TO CONNECT HER PROGRAMMER. A SUPPLEMENTAL
RECHARGER PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT I
PRODUCT TYPE EXTENSION PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID
PATIENT. . ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THEIR PATIENT PROGRAMMER REPLACED.
PROGRAMMER BUT THAT SHE WAS ABLE TO RECHARGE FINE. IT WAS NOTED THAT THE ISSUE REGARDING POCKET SITE HAD N
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-06858. IT WAS REPORTED THE PT'S IPG IS CAUSING HER DISCOMFORT
THE ISSUES. FOLLOW-UP IDENTIFIED THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2013 AND HER SCS LEAD WAS D
RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY T
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (
DUE TO THE EVENT INCLUDED HOSPITALIZATION. A CAT SCAN WAS PERFORMED. IT WAS UNKNOWN IF THERE WAS A PRODUC
TIME AND HAS BEEN IN INPATIENT REHABILITATION SINCE THE SURGERY. IT WAS NOTED THE PATIENT HAD BETTER MOVEMEN
THEIR RIGHT LEG AND THEY HAVE VERY LIMITED MOVEMENT. THE PATIENT �S LEG WILL SPASM SEVERELY WITH PASSIVE RANG
PAIN, PARALYSIS, SPASM AND WEAKNESS ALL IN THE RIGHT LEG, BLADDER AND BOWEL. THE DOCTOR NOTED THE PATIENT �S
NOT APPEAR TO BE IMPEDING THE SPINAL CORD IN ANY WAY. THE DOCTOR SPOKE WITH THE PATIENT ON WHETHER OR NOT
DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2013-19121. IT WAS REPORTED, THE PT HAD AN ANEURYSM TWO WEEKS
EXPLANTED THE SCS SYSTEM. THE PT WAS IN THE HOSPITAL FOR A MONTH THEN TRANSFERRED TO A REHABILITATION CENTE
DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2013-19122. IT WAS REPORTED, THE PT HAD AN ANEURYSM TWO WEEKS
EXPLANTED THE SCS SYSTEM. THE PT WAS IN THE HOSPITAL FOR A MONTH THEN TRANSFERRED TO A REHABILITATION CENTE
(B)(4). CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(
PRODUCT TYPE: RECHARGER. (B)(4). ADDITIONAL INFORMATION FROM THE PATIENT �S PHYSICIAN STATED THE CAUSE OF TH
RESULTS OF THE PATIENT�S MRI REVEALED A �SPINAL CORD CONTUSION.� IT WAS REPORTED THE PATIENT REQUIRED �E
PATIENT WOKE UP IN RECOVERY WITH LIMITED USE OF HER LEFT LEG AFTER IMPLANT. THE EVENT WAS DESCRIBED AS PARALY
PATIENT WAS SENT FOR AN MRI THE FOLLOWING DAY. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS REPORTED AS A
REC'D THE SURGICAL LEAD FOR A TRIAL WHICH WAS PLANNED TO GO TO PERMANENT. THE PT EXPERIENCED A BURNING SENS
AFTER THE IMPLANT. F/U IDENTIFIED THE PT HAD EXPERIENCED LEFT SIDED PARALYSIS WHICH BEGAN AFTER THE REMOVAL O
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THEY WERE UNABLE TO MAKE A DETERMINATION OF THE ISSUE AND A
SYSTEM WAS REMOVED ON THE SAME DAY. IT WAS NOTED THAT THE FEELING HAD RETURNED TO THE PATIENT �S LEGS BEFO
IMPLANT THE PATIENT IN A FEW WEEKS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. (B)
ANALYSIS OF BOTH LEADS FOUND THERE WAS NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE LEAD BODIES WERE CUT T
(B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PR
ANALYSIS IS COMPLETE. IT WAS REPORTED THAT DURING AND AFTER THE PROCEDURE THE PATIENT STATED THAT SHE WAS UN
WAS REMOVED THE PATIENT HAD BEGUN TO GET FEELING BACK INTO HER LEGS AND MOVEMENT. IT WAS NOTED THAT A CT S
DEVICE WAS STILL IMPLANTED WHEN THE CT SCAN WAS PERFORMED. THE SIGNS AND SYMPTOMS INCLUDED PARALYSIS. THE
HOSPITALIZATION.
(B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS �MASS EFFECT ON CORD. � IMAGIN
PATIENT OUTCOME WAS NOTED AS SERIOUS I NJURY/ILLNESS � ONGOING. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTE
PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYP
TYPE: PROGRAMMER. (B)(4). IT WAS REPORTED THAT ON THE DATE OF THIS REPORT, A LEAD REVISION WAS CONDUCTED DUE
WERE REPLACED WITH A SURGICAL PADDLE. IT WAS NOTED THAT THE LEAD WAS CONNECTED TO THE EXISTING GENERATOR. I
CONVERSED WELL IN THE POSTOPERATIVE AREA AND WAS INSTRUCTED NOT TO TURN ON STIMULATION UNTIL THE 10 DAY PO
THE EMERGENCY ROOM DUE TO A REPORTED LOSS OF SENSATION IN THE LOWER EXTREMITIES. IT WAS NOTED THAT A COMP
SENSATION. COMPLICATIONS INCLUDED PARALYSIS OF THE LOWER EXTREMITIES. HOSPITALIZATION OCCURRED AS A RESULT O
INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.
CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_R
IMPLANTABLE NEUROSTIMULATOR IMPLANTED AND EXPLANTED THE SAME DAY. IT WAS NOTED THAT NO OTHER ATTEMPTS W
THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT'S PARALYSIS RESOLVED AFTER THE SYSTEM
WAS FURTHER REPORTED THAT THERE WAS A MANUFACTURE REPRESENTATIVE AT THE IMPLANT/EXPLANT PROCEDURE ON (B
THE DEVICE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID
REPRESENTATIVE WAS AWARE OF THIS EVENT ON (B)(6) 2013, AWARE DATE OF THE NEW INFORMATION IS (B)(6) 2013. IT WAS
IT WAS NOTED THE MANUFACTURING REPRESENTATIVE WAS CHARGING THE INS IN THE RECOVERY ROOM. THE REPORTER STA
WAS FURTHER NOTED THE PARALYSIS RESOLVED WHEN THE SPINAL CORD STIMULATION SYSTEM WAS REMOVED. THE REPOR
APPOINTMENT WITH THEIR HEALTHCARE PROFESSIONAL (HCP) TO DISCUSS THE PARALYSIS. IT WAS FURTHER NOTED THE PAT
HAVING TROUBLE WITH THEIR BACK PAIN BECAUSE OF HEALING AND A PRE-EXISTING PAIN CONDITION WHICH WAS WHY THE
NOTED THE PATIENT WANTED TO GET THE INS BECAUSE THE TRIAL RELIEVED THEIR PAIN SO WELL. ADDITIONAL INFORMATION
CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3776-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRO
IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. IT WAS STATED THAT THE PATIENT USED HIGH AMPLITUDE TO COVER
SENSOR TO CONTROL PATIENT LEAN BACKWARD AND CONTROL OVERSTIMULATION. IT WAS ALSO NOTED THERE WAS NO DEV
REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE OF THEIR P
SYSTEM WAS REMOVED AND A NEW DEVICE SYSTEM WAS IMPLANTED. AFTER ACTIVATION OF THE NEW DEVICE EVERYTHING
PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTE
(B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
(B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED WHEN THE PATIENT WAS GOING FROM A PERCUTANEOUS LEAD TO TH
SURGEON WAS TRYING TO IMPLANT THE LEAD IT WAS SLIDING TO THE RIGHT AND BRUISED THE PATIENTS SPINAL CORD. IT W
WERE IN THE ICU FOR BLOOD PRESSURE MANAGEMENT TO HELP RECOVER FROM THE INJURY. A CT SCAN CONFIRMED THE LE
SURGERY". THE LEAD WAS THEN EXPLANTED ON (B)(6) 2013 AND THE PATIENT RETURNED TO ICU FOR BLOOD PRESSURE MAN
THEN MOVED TO A REHAB HOSPITAL FOR 28 DAYS. THE PATIENT REGAINED SOME MOVEMENT ON RIGHT SIDE AND FULL MOV
ANKLE GIVES OUT AND THE BRUISE ON THE RIGHT SIDE HAS HEALED/MATURED. THE PATIENT WAS REDIRECTED TO THEIR HCP
(B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT
37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 20
TYPE LEAD; PRODUCT ID 3550-39, LOT # N319565, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSO
SYNDROME OF UPPER EXTREMITY AND THE PATIENT HAD RETURNED TO SURGERY TWO MONTHS AGO TO HAVE A NEW LEAD
THE PATIENT EXPERIENCED A SIGNIFICANT NEUROLOGIC DEFICIT WITH QUADRIPARESIS, INCLUDING LOSS OF MOTOR FUNCTIO
OF LEAD. THE PATIENT REGAINED SOME MOTOR AND SENSORY FUNCTION AFTER BEING PLACED ON STEROIDS; HOWEVER, BE
TO A REHABILITATION FACILITY TO CONTINUE RECOVERY. IT WAS NOTED THAT THE DEVICE WAS NEVER TURNED ON POSTOPER
37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3550-29, LOT# N313965, IMPLANTED: (B)(6) 2012. PRODUCT
(6) 2013. PRODUCT TYPE: LEAD. (B)(4). IT WAS REPORTED THE PATIENT EXPERIENCED WEAKNESS AND LOSS OF FEELING IN THE
THE ICU WITH CONDITION IMPROVING AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION REPORTED THE DEVICE WAS
EPIDURAL SPACE RESULTED IN EXCESSIVE PRESSURE WITH THE LEAD IN PLACE. ADDITIONAL INFORMATION RECEIVED REPORTE
COMPLETELY.� THE REPORTER STATED THAT FOUR DAYS LATER THE �LEFT SIDE CAME BACK SLOWLY. � IT WAS NOTED THAT
ADDITIONAL INFORMATION RECEIVED REPORTED THAT SEVERAL ELECTRODES HAD HIGH IMPEDANCE BUT IT WAS CHANGED O
WAS FURTHER NOTED THAT THE PATIENT HAD SPASTICITY AND THAT THE STIMULATION WAS CAUSING THE PATIENT TO SHAKE
PUT IN A PADDLE LEAD TO ADDRESS THE ISSUES. IT WAS NOTED, HOWEVER, THAT THE ROOT CAUSE OF THE SYMPTOMS WAS N
NOTED AS DOING WELL AND THERE WERE NO ISSUES TO REPORT AT THAT TIME. (B)(4). IT WAS REPORTED, THE PATIENT HAD A
NOTED THIS WAS OBSERVED DURING AN IMPEDANCE AND PROGRAMMING SESSION. IT WAS STATED, THE PATIENT FELT STIMU
OVER ON THEIR SKIN. IT WAS NOTED, THE SHAKING SENSATION WOULD LAST FOR ABOUT 10-15 SECONDS AFTER THE IMPLAN
�POP.� THE PATIENT THEN STARTED FEELING SENSATIONS AND HAD A SHAKING SENSATION AND WENT TO THE EMERGENC
STATUS WAS SERIOUS. REPORTEDLY, THE PATIENT WAS BEING SENT TO HAVE X-RAYS DONE. IT WAS ALSO REPORTED THERE WE
WAS NOTED, THE PATIENT TYPICALLY HAD THEIR STIMULATION AT 4.5 VOLTS BUT THE DAY OF REPORT THEY COULD ONLY TOLE
SUPPLEMENTAL REPORT WILL BE FILED. . PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE L
PATIENT PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4). ADDITIONAL INFORM
PATIENT WAS SCHEDULED FOR A REVISION AND IMPLANT OF A PADDLE LEAD. APPROXIMATELY THREE WEEKS LATER, IT WAS R
PATIENT WAS RECEIVING STIMULATION IN HER TARGET AREAS OF PAIN AND WAS VERY HAPPY WITH HER NEW SYSTEM.
DEVICE 1 OF 3. REF MFR REPORTS: 1627487-2013-05882 AND 1627487-2013-05883. THE PT HAD TWO LEADS FROM THE SAM
NO LONGER IMPLANTED WITH AN SJM SCS SYSTEM. AFTER EACH OF THE PROCEDURES, THE PT BECAME VERY ILL, EXPERIENCE
HER TO DEVELOP REFLEX SYMPATHETIC DYSTROPHY, FIBROMYALGIA, A SEIZURE DISORDER, MIGRAINES, AND BLADDER INFECT
RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S
OF 3. REF MFR REPORTS: 1627487-2013-05881 AND 1627487-2013-05883. THE PT HAD TWO LEADS FROM THE SAME LOT. IT W
LONGER IMPLANTED WITH AN SJM SCS SYSTEM. AFTER EACH OF THE PROCEDURES, THE PT BECAME VERY ILL, EXPERIENCED D
DEVICE 3 OF 3. REF MFR REPORTS: 1627487-2013-05881 AND 1627487-2013-05882. THE PT HAD TWO LEADS FROM THE SAM
NO LONGER IMPLANTED WITH AN SJM SCS SYSTEM. AFTER EACH OF THE PROCEDURES, THE PT BECAME VERY ILL, EXPERIENCE
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3999-60, LOT# VA05VCW, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013
(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER
MOTOR CONTROL OF LEGS POST OPERATION. THE PATIENT ALSO EXPERIENCED PARALYSIS AND LOSS OF REFLEXES IN LOWER E
DECOMPRESSION SURGERY WAS PERFORMED AND LEAD WAS REMOVED. THE PATIENT WAS HOSPITALIZED. THE PATIENT OUTC
THE DATE OF THIS REPORT. . IT WAS FURTHER REPORTED THAT THE PATIENT WAS STILL IN THE HOSPITAL, IN THE IN-PATIENT R
REPRESENTATIVE VISITED THE PATIENT REGULARLY TO KEEP THE BATTERY CHARGED IN CASE THE PATIENT WOULD LIKE TO ADD
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS AT THEIR HEALTHCARE PROFESSIONAL �S (HCP) OFF
WAS NOTED THE PATIENT INITIALLY FELT AN 80 PERCENT REDUCTION IN PAIN USING STIMULATION AND ORAL MEDICATION. I
PATIENT FELT PARALYSIS FROM THE WAIST DOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUTWAS NOT AVAILABLE AS
39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE:
NEEDED TO USE A WALKER, AND CANNOT EVEN STAND UP BY HERSELF IN THE SHOWER. � IT WAS ALSO STATED THE PATIENT �
TOMOGRAPHY (CT) SCAN. IT WAS NOTED THE PATIENT HAD A DIFFERENT DEEP PAIN FROM THE WAIST DOWN WHICH "WAS W
OFF. THE SYMPTOMS STARTED A COUPLE OF WEEKS AGO. THE STIMULATION TARGET WAS FROM THE WAIST DOWN AND INITI
SUBSIDED. IT WAS FURTHER NOTED THAT THE PATIENT WAS "BREAKING OUT" IN BROWN SPOTS "ALL OVER HER BODY" WHICH
PATIENT REPORTEDLY RECEIVED A STEROID SHOT FOR THE KNEE. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF
INDICATED THE HEALTHCARE PROVIDER (HCP) DID NOT BELIEVE THERE WAS ANYTHING WRONG WITH THE DEVICE. IT WAS STA
REFERENCE MFR REPORT: 1627487-2013-04710. IT WAS REPORTED THE PT HAD PAIN AT THE LEAD SITE, AND WAS ADMITTED
IDENTIFIED THE PT WAS BACK HOME. THE PT REPORTED HE HAD PARALYSIS FROM THE WAIST DOWN DURING THE HOSPITAL S
IT WAS REPORTED THE PT'S DAUGHTER COULD BOTH SEE AND FEEL SOMETHING NEAR THE LEAD SITE WHICH WAS ATTEMPTIN
DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-03738 AND 1627487-2013-03739. THE PATIENT REPORTED, SHE EXPE
NOW NON-FUNCTIONAL. THE PATIENT ALSO REPORTED, THE CHEST PAIN BEGAN SINCE IMPLANT. THE PHYSICIAN BELIEVES TH
DETERMINED THERE MAY BE A RISK OF PARALYSIS. THE PATIENT STATED, SHE WILL BE SCHEDULING AN APPOINTMENT WITH T
AT A LATER DATE. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED T
SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT I
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND "NO ANOMALY." ANALYSIS OF THE LEAD FOUND THE PRODUCT W
RETURN TO THE HOSPITAL THE NIGHT AFTER IMPLANT DUE TO COMPLICATIONS RELATED TO THE IMPLANT SURGERY. IT WAS S
AN INFECTED KIDNEY THE PATIENT HAD PRIOR TO IMPLANT �. THE PATIENT WAS IN A TREMENDOUS AMOUNT OF PAIN. IT WA
MOVE THEIR LEGS. IT WAS ALSO STATED THE ENTIRE SYSTEM WAS EXPLANTED FOLLOWING A CT SCAN. IT WAS ALSO REPORTE
(B)(4). IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AFTER A FALL ON HIS BACK ON (B)(6) 2013.
OF PAIN. THE PATIENT SUSPECTED THERE WAS SOMETHING WRONG WITH HIS LEAD DUE TO THE INTERMITTENT STIMULATION
HIS PHYSICIAN ON (B)(6 )2013. IT WAS FURTHER REPORTED THAT A COMPANY REPRESENTATIVE MET WITH THE PATIENT. IMPE
PLANNED TO TRY THE PROGRAM FOR A WHILE. OF NOTE, THERAPY WAS MINIMAL. THE PATIENT REPORTEDLY FELL FREQUENT
(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE
FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THEY HAD SEEN THE PAT
THE IMPLANTABLE NEUROSTIMULATOR (INS) OR IT �S PLACEMENT BUT THAT THE PATIENT REQUESTED THE INS BE REMOVED
MADE UP THEIR MIND TO HAVE THE DEVICE REMOVED. IT WAS NOTED THAT THE HCP HAD SEEN THE PATIENT TWO TIMES, ON
REPORTED AS DOING WELL AND WAS USING A WALKER AT THE VISIT. IT WAS UNKNOWN IF THE PATIENT �S FIBROMYALGIA W
THE PATIENT'S SPINE. THE DEVICE WAS REPORTEDLY TAKEN OUT AND PLACED ON THE PATIENT SIDE. AFTER THIS THE PATIENT
USING A CANE, THEN A WALKER 2-3 WEEKS LATER, AND THEN A WHEELCHAIR. IT WAS FURTHER REPORTED THAT THE PATIENT
THERAPY AND HER ABILITY TO WALK IS COMING BACK. IT WAS FURTHER NOTED THAT "THEY PRETTY MUCH FIGURED, IT WAS
AVAILABLE AS OF THE DATE OF THIS REPORT. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE:
PRODUCT ID 3487A-33, LOT # J0327021V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ51, SERIAL # (B)(
PRODUCT ID 7495LZ51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(
MANAGEMENT HAD BEEN A PROBLEM. IT WAS ALSO REPORTED THE HEALTHCARE PROVIDER HAD NOT USED THE PATIENT PRO
NOTED THE PATIENT HAD PAIN ISSUES ON AND OFF SINCE THEY WERE FIRST ADMITTED TO A NURSING HOME ON (B)(6) 2012.
TO THE PATIENT'S HEALTHCARE PROVIDER. FOUR DAYS LATER, IT WAS REPORTED THE HEALTHCARE PROVIDER WAS NOT ABLE
SWITCHED THE SETTING TO AMPLITUDE AND WAS THEN REPORTEDLY ABLE TO VIEW THE LIGHTS ON THE PROGRAMMER AND
FELT STIMULATION. IT WAS ALSO NOTED THE PATIENT WAS IN A WHEELCHAIR AND DID NOT HAVE THE COGNITIVE ABILITY TO
PROVIDER DID NOT KNOW IF THE INS WAS WORKING AND WAS ADVISED TO CALL BACK WHEN THE PATIENT WAS MORE ALERT
EVENT. IT WAS FURTHER STATED THAT IT WAS "UNKNOWN" WHETHER THE IMPLANTABLE NEUROSTIMULATOR (INS) OR THE LE
IN HEALTH AND COGNITION" "DUE TO THE PROGRAMMING OR THE PROGRAMMER" AND WOULD BE REASSESSED WHEN THE
OUTCOME WAS REPORTED AS "SERIOUS INJURY/ILLNESS - ONGOING" AND IT WAS NOTED THE PATIENT HAD "BILATERAL DVT"
FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
(B)(4). PRODUCT ID 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 8591-38 LOT# D17525, IMPLANTED:
LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). IT WAS REPORTED THAT THE PATIENT WAS IN A WHEELCH
WERE BELOW THE SCAR. THE PATIENT DIDN �T KNOW IF THEIR HEALTH CARE PROVIDER (HCP) STUCK THEM IN THERE AND PU
INFORMATION RECEIVED REPORTED THAT THE PATIENT �S WHEELCHAIR WAS NOT REQUIRED PRIOR TO IMPLANT. THE PATIEN
THAT THEY PATIENT HAD SPINAL STENOSIS. THE PATIENT HAD SURGERY TO CORRECT THIS IN JULY. IT WAS REPORTED THAT AFT
CURRENT PAIN NEEDS. THE PATIENT WAS GETTING EXCELLENT COVERAGE AND WAS VERY HAPPY WITH THEIR IMPLANT AND H
EFFECT. WHEN THE PATIENT TURNED STIMULATION UP TO 1.0 VOLTS, THE STIMULATION WAS UN COMFORTABLE. IT WAS NOT
WHEN THEY GO OUT. IT WAS NOTED AN MRI SHOWED STENOSIS WHERE THE LEAD "HAD TO BE PLACED."IT WAS NOTED, THE
"NO ONE WOULD SEE THE PATIENT AFTER THE SURGERY BECAUSE THEY HAD JUST BEEN IMPLANTED." IT WAS NOTED, THE PAT
MORPHINE BUT IT HAD NOT BEEN WORKING. IT WAS REPORTED, THE HEALTH CARE PROFESSIONAL "CUT THE PATIENT'S SPINE
BEEN IN "INCREDIBLE" PAIN IN THEIR LOWER BACK. IT WAS NOTED, THE PATIENT WOULD NEED TO HAVE ANOTHER SURGERY F
WAS "VERY HAPPY NOW AND THEIR COVERAGE WAS BETTER THAN EVER." FOLLOW UP REPORTED, THE PATIENT DID NOT HAV
WERE RESOLVED. AN APPOINTMENT WAS NOTED FOR (B)(6) 2013.
IT WAS REPORTED THE PATIENT'S IMPLANTED NEUROSTIMULATOR (INS) WAS REMOVED AFTER 2-3 DAYS OF IMPLANT. IT WAS
REPORTED THE DEVICE SYSTEM WAS EXPLANTED BECAUSE THE PATIENT HAD DEVELOPED FURTHER WEAKNESS IN HER BILATE
BASELINE STRENGTH AND FUNCTION AND THEN DEVELOPED WEAKNESS. A CT SCAN WAS PERFORMED WITH NO DEFINITIVE D
REGARDS TO HER STRENGTH AND FUNCTION. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B
IT WAS REPORTED THAT THE LEAD HAD BEEN EXPLANTED DUE TO SPINAL HEMATOMA WITH COMPRESSION OF MARROW. PAT
ASSISTANCE, AND USED WHEELCHAIR TO GO OUTSIDE. HOSPITALIZATION, MEDICAL, AND SURGICAL INTERVENTIONS WERE RE
THERE WAS ALSO PARESTHESIA IN THE LOWER PART OF THE BODY UP TO THE NAVEL, WITH A LOSS OF SENSITIVITY. IT WAS ALS
BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THAT THE PATIENT WOULD "FOLLOW UP IN REEDUCATION" AND THAT THE PATIENT WAS SATISFIED WITH NEUROMODULATION
HEMATOMA THE PATIENT FELT BETTER, BUT STILL HAD PAIN IN THE ANTERIOR THIGH. THE PATIENT HAD FOLLOW UP RE-EDUC
30, LOT# 0206298383, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4). IT WAS LATER REPORTE
STATED THE PATIENT�S LEAD WAS REMOVED. . IT WAS PREVIOUSLY REPORTED THAT THE PATIENT WAS "SATISFIED WITH NEU
THE PATIENT OUTCOME FOR THIS EVENT IS CURRENTLY UNKNOWN, BUT FOLLOW UP IS BEING CONDUCTED.
IT WAS REPORTED THAT THE PATIENT DEVELOPED "PARALYSIS 24 HOURS POST OPERATION." IT WAS NOTED THAT THE PATIENT
HEALTH CARE PROFESSIONAL (HCP) NOTED "NOTHING UNUSUAL" AND "NO SIGNIFICANT BLEEDING." IT WAS NOTED THAT AFT
WAS PERFORMED IN A THIRD SURGERY TO RELIEVE THE CLOT AND THE PRESSURE IT WAS PLACING ON THE SPINAL CORD. IT W
HOURS. IT WAS FURTHER NOTED THAT THE PATIENT WAS TRANSPORTED TO A REHAB CENTER. IT WAS NOTED THAT THE CAUS
PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODU
FOLLOW UP INFORMATION REPORTED THAT THE PATIENT HAD RECOVERED THE FEELING IN THEIR LEGS AND WOULD NOT BE G
ADDITIONAL INFORMATION RECEIVED NOTED THAT THE STIMULATOR HAD TO BE REMOVED IMMEDIATELY AFTER IMPLANT DU
(B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37744 LOT# SERIAL# (B)(4), PROD
ALL FEELING IN THEIR LEGS." IT WAS FURTHER REPORTED THAT FOLLOWING IMPLANT SURGERY, THE PATIENT EXPERIENCED "N
STATED THAT WHEN THE DEVICE WAS REMOVED, "THE SITE OF THE LEAD WAS SWOLLEN." IT WAS NOTED THE PHYSICIAN PLAC
IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION STATED THE PATIENT �S MAIN DEVICE WAS THE FIRST ONE HE PUT IN AND IT DID �A LOT OF GO
THE BACK. INFORMATION INDICATED THE PATIENT �S NUMBNESS WAS RELATED TO THE PATIENT �S PRIMARY IMPLANT THAT
REPORT #3004209178-2013-07085 FOR THE OTHER PERIPHERAL NEUROSTIMULATOR. IT WAS REPORTED THE PATIENT HAD A
THOSE TWO DEVICES SET AT 6.0 VOLTS AND THEY WERE "NOT DOING AS MUCH" BECAUSE THE PATIENT'S PAIN LOCATION WAS
HAD BEEN REPROGRAMMED EIGHT TIMES AND THE PATIENT STATED "IT WAS AS GOOD AS IT GETS." IT WAS ALSO REPORTED T
A SCOOTER OR WHEELCHAIR, OR CRUTCHES FOR SHORT DISTANCES. IT WAS ALSO STATED THE PATIENT HAD NUMBNESS DOW
PRESCRIBE." THE PATIENT REPORTEDLY DID NOT USE THE TWO DEVICES IN THE BACK DUE TO THE BURNING BUT HE DID USE T
"REVISION" SURGERY DUE TO A "LEAD BREAK." A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOM
OF THIS, A REPORT WAS FILED ON ALL THREE OF THE DEVICES. PLEASE SEE MFR REPORT # 3004209178-2013-07083. (B)(4). PR
ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: RECHARGER. PRODUCT ID: 377745, LOT# N0030362, IMPL
3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# V042634, IMPLAN
LOT# V042640, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V042640, IMPLANTED: (B)(6) 200
CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752,
377745, LOT# N0030362, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT# N0042225, IMPLANTED: (
V042634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# V042634, IMPLANTED: (B)(6) 2007, PROD
IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE
(B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD;
2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION
�PLACED PERFECTLY.� IT WAS NOTED THIS DEVICE COVERED THE WAIST DOWN, AND THE TWO PERIPHERAL STIMULATORS C
PATIENT'S PERIPHERAL NEUROSTIMULATORS. SEE MANUFACTURER REPORT # 3004209178-2013-07084 AND # 3004209178-20
SENSATION WHEN THEY TURNED ON TWO OF THEIR PERIPHERAL IMPLANTABLE NEUROSTIMULATORS (INS). THE PATIENT REPO
MIDDLE OF THEIR SPINE. THE PATIENT STATED THE 'ELECTRICITY IS JUST AS BAD AS THE PAIN.' IT WAS ALSO REPORTED THE PAT
HAD SPINAL STENOSIS FROM AN INJURY AT WORK AND HAD A SURGERY DONE THAT 'MESSED UP A DISC.' IT WAS NOTED THE
OF THEIR LEG, PAIN DOWN THE FRONT OF THEIR LEG AND THEIR BACK WAS 'RIDICULOUS NO MATTER WHAT THE DOCTORS DO
AND IT WAS SET AT 10.5 VOLTS. ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN INDICATED THE PATIENT UNDERW
UNKNOWN AT THE TIME OF REPORT WHICH TWO OF THE PATIENT'S THREE IMPLANTED DEVICES WERE REFERENCED. BECAUS
(B)(4). IT WAS REPORTED, THE PATIENT HAD A BURNING SENSATION WHEN THEY TURNED ON TWO OF THEIR PERIPHERAL IMP
BECAUSE THE PATIENT'S PAIN LOCATION WAS IN THE MIDDLE OF THEIR SPINE. THE PATIENT STATED THE "ELECTRICITY IS JUST A
GOOD AS IT GETS." IT WAS ALSO REPORTED, THE PATIENT HAD SPINAL STENOSIS FROM AN INJURY AT WORK AND HAD A SURG
ALSO STATED, THE PATIENT HAD NUMBNESS DOWN THE BACK OF THEIR LEG, PAIN DOWN THE FRONT OF THEIR LEG AND THEI
DUE TO THE BURNING BUT HE DID USE THE "MAIN" DEVICE AND IT WAS SET AT 10.5VOLTS. ADDITIONAL INFORMATION FROM
FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IT WAS UNKNOWN AT THE TIME OF REPORT WHICH TWO OF THE P
REPORT # 3004209178-2013-07083 AND # 3004209178-2013-07084 FOR INFORMATION ON THE PATIENT'S OTHER DEVICES. P
PRODUCT TYPE RECHARGER PRODUCT ID 377745 LOT# N0030362, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID
TYPE EXTENSION PRODUCT ID 3888-33 LOT# V042634, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3888-33 LO
PRODUCT ID 3888-45 LOT# V042640, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-45 LOT# SERIAL# (B)(4)
PRODUCT ID 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3777-45 LOT# SE
EXTENSION PRODUCT ID 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3708
WAS THE FIRST ONE HE PUT IN AND IT DID "A LOT OF GOOD" AND WAS "PLACED PERFECTLY." IT WAS NOTED THIS DEVICE COV
RELATED TO THE PATIENT'S PRIMARY IMPLANT THAT COVERS THE WAIST AND DOWN. SEE MANUFACTURER REPORT # 300420
NEUROSTIMULATOR.
(B)(4). (B)(4) CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUC
WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANT SITE AND IN THE LEG. IT WAS NOTED THAT THE PATIE
THE DEVICE BUT COULD NOT BECAUSE IT WAS TOO PAINFUL WHEN DEVICE WAS TURNED ON. IT WAS NOTED THAT MANUFAC
THEM AGAIN TO TAKE IT OUT.' IT WAS FURTHER NOTED THAT PATIENT BENT OVER 'ABOUT 2 MONTHS AGO' PRIOR TO THE REP
PAIN. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS UNABLE TO 'PIN POINT' THE CAUSE OF PAIN AT THE T
A LOT OF PAIN IN HER LEFT LEG ALL THE WAY DOWN TO HER TOE.' IT WAS FURTHER NOTED THAT THE MANUFACTURING REPR
THAT THE DEVICE HAD NOT BEEN TURNED ON SINCE THE TEST. IT WAS NOTED THAT THE HCP WAS UNABLE TO DO AN MRI BEC
PATIENT 'CAN HARDLY RIDE IN A CAR' BECAUSE OF THE PAIN. IT WAS FURTHER NOTED THAT THE REPORTED WAS SAYING PATIE
WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
I HAD A SPINAL CORD STIMULATOR PUT IN, TAKEN OUT, PUT BACK IN, TAKE OUT AGAIN. IT WAS AN ANS UNIT WITH THE REP T
LIDOCAINE ON MY BACK WHEN THEY CUT IN AND ALSO PLACED THE LEADS. I FELT EVERY PLACEMENT AND EVERY CUT. AFTER
WAS JUST THE FLU AND MY SON GAVE IT TO ME. BUT EVERY TIME I TURNED ON THE SCR I BECAME ILL. I HAVE NEVER BEEN LI
PARENTS' STAIRCASE AND RIPPED THE SITE WHERE THE STIMULATOR STITCHES WERE. I TO THIS DAY CAN'T SLEEP ON MY BACK
MIGRAINES, BLADDER INFECTIONS ALL THE TIME. NOW MY LIFE IS SPENT AT THE DOCTOR'S OFFICE SO MUCH TRYING TO REPA
THE SCS BECAUSE I HAVE HUGE TRUST ISSUE NOW BECAUSE HOW THIS SURGERY WAS DONE. I QUESTION THE HECK OUT OF D
PAIN SO I DON'T HAVE TO TAKE PILLS, SHOTS OR ANYTHING TO RUIN MY BODY BUT INSTEAD THIS THING HAD ME IN A WHEEL
DOCTOR'S PHONE NUMBER: (B)(6).
(B)(4). (B)(4) IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE THE PERMANENT IMPLANT ON (B)(6), 2013 FOR
THE HCP REMOVED ALL THE DEVICES ON (B)(6) 2013 DURING THE IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN R
LAMINECTOMY WAS PERFORMED WITH EPIDURAL ANESTHESIA. THE LEAD WAS PLACED AND DURING TESTING THE PATIENT R
HOURS WHILE THE SENSORY CHANGES RESOLVED OVER THE NEXT FEW DAYS. THERE WAS NO PERMANENT SEQUELA, AND IT W
THE PROCEDURE, AND THE PATIENT RECOVERED WITHOUT SEQUELA.
(B)(4). IT WAS REPORTED THE PATIENT HAD PARALYSIS IN BOTH OF THEIR LEGS FOLLOWING A REVISION OF THEIR LEAD. IT WA
NEUROSTIMULATOR (INS) REMAINED IMPLANTED. THE PATIENT'S STATUS WAS REPORTED AS ALIVE WITH INJURY. TWO DAYS L
EXPLANTED, THE SITUATION WAS REPORTED TO BE 'NEARLY NORMAL.' ADDITIONAL INFORMATION STATED THE PATIENT WAS
LATER, IT WAS REPORTED THE PATIENT WAS WELL, COULD WALK AGAIN, AND HAD GONE HOME. IT WAS ALSO NOTED THE PAT
LOT #) PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN, PRODUCT TYPE LEAD. ANALYSIS RESULTS WERE NOT AVA
37702, SERIAL # (B)(4) SHOWED NO ANOMALIES. ANALYSIS OF LEAD MODEL 39565-30, SERIAL # (B)(4) SHOWED NO SIGNIFICA
WAS NOT RETURNED). THE CONTINUITY WAS ACCEPTABLE AND NO SHORTS WERE SEEN BETWEEN THE CIRCUITS. CONCOMITA
SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37081-60, SERIAL#
(B)(4). CONCOMITANT PRODUCTS: PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PR
PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). IT WAS STAT
WHEELCHAIR." IT WAS STATED THAT WHEN THE PATIENT GOT TO THE CAR, HE TOLD HIS WIFE "IT WASN'T WORKING RIGHT, SO
A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
OF 3. REFERENCE MFR REPORT: 1627487-2013-06172, REFERENCE MFR REPORT: 1627487-2013-06173. IT WAS REPORTED, TH
SYSTEM AND HE STOPPED USING THE IPG ABOUT EIGHT MONTHS AGO. THE PATIENT REPORTED, HE IS NOT ABLE TO COMMUN
IN COMMUNICATING WITH IPG ALSO. THE PATIENT HAS BEEN WHEELCHAIR BOUND DUE TO AN ANKLE INJURY AND HAS GAIN
LATER DATE.
DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2013-06172, REFERENCE MFR REPORT: 1627487-2013-06174. IT WAS REPO
FROM THE SYSTEM AND HE STOPPED USING THE IPG ABOUT EIGHT MONTHS AGO. THE PATIENT REPORTED, HE IS NOT ABLE T
UNSUCCESSFUL IN COMMUNICATING WITH IPG ALSO. THE PATIENT HAS BEEN WHEELCHAIR BOUND DUE TO AN ANKLE INJURY
THE IPG AT A LATER DATE. THIS CHARGER MODEL WAS ASSOCIATED WITH A FIELD CORRECTION. MANUFACTURER'S EVALUATIO
FOR CAPA (B)(4) ASSOCIATED WITH HEATING WHILE CHARGING (POCKET HEATING) CONCLUDED THAT THE CHARGER WAS CAP
TEMPERATURE TO CAUSE PAIN AND BURNS. THE HEATING WHILE CHARGING WAS DETERMINED TO BE EXACERBATED BY OFF-A
RECALL NUMBER: 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD
WAS REPORTED THE PATIENT EXPERIENCED HEATING WHILE CHARGING THE IPG. THE PATIENT ALSO REPORTED HE WAS NOT R
ABLE TO COMMUNICATE WITH THE IPG USING THE CHARGER OR THE PATIENT PROGRAMMER. AN SJM REPRESENTATIVE MET
INJURY AND HAS GAINED A SIGNIFICANT AMOUNT OF WEIGHT. THE PATIENT HAS BEEN SCHEDULED TO MEET WITH HIS PHYSI
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL/LOT#: (B)(4), D
STERILE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. . A REP
MULTILEVEL HEMATOMA ON THE ANTERIOR PORTION OF THE SPINAL CORD. AFTER THE MRI THE PATIENT UNDERWENT A 5-L
RELATED. THE PATIENT HAS BEEN SENT TO A REHABILITATION CENTER AND HAS STARTED REGAINING MOVEMENT IN HIS QUAD
(B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL:SC-2218-50E, SERIAL/LOT: (B)(
WERE DISCARDED BY THE MEDICAL FACILITY. A REPORT WAS RECEIVED THAT FOLLOWING THE EXPLANT OF THE TRIAL LEADS T
TO REMOVE THE HEMATOMA AND THE PATIENT REGAINED FULL MOVEMENT OF HIS LEGS.
IT WAS REPORTED THAT THE PATIENT WAS HIT BY A CAR WHILE IN HIS MOTORIZED WHEELCHAIR ON (B)(6) 2012 AND HAD NO
WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) CHARGE LEVEL AND INDICATED HE WAS TRAINED ON THE DEVICE WHILE U
APPOINTMENT SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT DIDN �T USE THE INS BECAUSE IT "D
IT WAS REPORTED THAT THE PATIENT WAS HIT BY A CAR WHILE IN HIS MOTORIZED WHEELCHAIR ON (B)(6) 2012 AND HAD NO
WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) CHARGE LEVEL AND INDICATED HE WAS TRAINED ON THE DEVICE WHILE U
APPOINTMENT SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT DIDN'T USE THE INS BECAUSE IT 'DID
PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V660238, IM
3888-45, LOT# V603270, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE R
NEUROSTIMULATOR; PRODUCT ID 37713, SERIAL# (B)(4), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).
THIS CHARGER MODEL WAS ASSOCIATED WITH A FIELD CORRECTION. CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIG
CHARGING (POCKET HEATING) CONCLUDED THAT THE CHARGER WAS CAPABLE OF TRANSFERRING ENERGY TO THE IPG AT A RA
HEATING WHILE CHARGING WAS DETERMINED TO BE EXACERBATED BY OFF-AXIS CHARGING OF SHALLOW IMPLANTED IPGS A
UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT
PARALYSIS IN THE LEGS FOR ABOUT 7 HOURS, BUT HAD NOT CONTACTED ANYONE DURING THE EPISODE. IN ADDITION, THE PT
ANOMALIES. A REPLACEMENT CHARGING SYSTEM WAS PROVIDED TO THE PT. FOLLOW UP IDENTIFIED THE PT HAD NOT EXPER
WITH CHARGING RECOMMENDATIONS IN CASE HEATING RETURNED.
REFERENCE MFR REPORT: 1627487-2013-04368, 04369. IT WAS REPORTED THE PT HAD PARALYSIS IN THE LEGS FOR ABOUT 7 H
THE IPG. THE PHYSICIAN HAD A CT SCAN PERFORMED WHICH DID NOT SHOW ANY ANOMALIES. A REPLACEMENT CHARGING S
REPLACEMENT CHARGING SYSTEM HAD RESOLVED THE HEATING ISSUE. THE PT WAS PROVIDED WITH CHARGING RECOMMEN
THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S ME
PHYSICIAN REGARDING MEDICAL HISTORY. DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2013-04367, 04369. IT WAS REP
SOME HEATING SENSATION OF THE SKIN WHILE CHARGING THE IPG. THE PHYSICIAN HAD A CT SCAN PERFORMED WHICH DID
ANY FURTHER PARALYSIS SYMPTOMS, AND THE REPLACEMENT CHARGING SYSTEM HAD RESOLVED THE HEATING ISSUE. THE P
A REPORT WAS RECEIVED THAT FOLLOWING THE TRIAL LEAD EXPLANT THE PATIENT WAS EXPERIENCING WEAKNESS AND WEN
RELATED. THE PATIENT WAS SUFFERING FROM NEUROLOGICAL DEFICIT WHICH INCLUDED PARALYSIS IN ALL FOUR LIMBS. THE
THE PATIENT IS CURRENTLY IN A LONG TERM IN-PATIENT REHABILITATION CENTER AND IS SLOWLY REGAINING PARTIAL USE OF
DESCRIPTION: ST LINEAR TRIAL LEAD, 70CM WITH PRE-LOADED 0.014 INCH STYLET.
IT WAS REPORTED THE PT ((B)(6)) RECEIVED EFFECTIVE STIMULATION AND PARESTHESIA IMMEDIATELY FOLLOWING THE PROC
WITH A TOTAL LACK OF SENSITIVE MOTOR RESPONSE FROM BOTH LOWER EXTREMITIES. THE PHYSICIAN PERFORMED RADIOLO
VALUES, BUT NO PARESTHESIA/STIMULATION FELT BY THE PT. THE LEAD, LEAD EXTENSION AND ANCHOR WERE ALL EXPLANTED
REHABILITATION PROGRAM. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FOR
HISTORY.
FINE FOR A WHILE, BUT THE PATIENT NOW FELT STIMULATION AGAIN IN HER CHEST, NEAR HER HEART. THE PATIENT HAD BEEN
SHE WAS FEELING AN ELECTRICAL SHOCK IN THE POCKET OR JUST PHYSICAL PAIN. THE PATIENT ALSO STATED SHE TORE LIGAM
DOCTOR ANYMORE AND THAT THEY PATIENT HAD BEEN GOING WITHOUT MEDICATION. THE PATIENT STATED WOULDN'T EVE
IMMUNE TO IT. THE PATIENT NOTED THAT THEY WENT TO THE HOSPITAL (B)(6) 2014 BECAUSE THE PATIENT THOUGHT THAT TH
NOTED THAT ALL THEY COULD GIVE WAS FOUR PILLS. THE PATIENT NOTED THAT THEY WERE THE ONE BEING TORTURED AND
DOCTOR AND THE DOCTOR REFUSED TO SEE THEM. THE PATIENT DID NOT KNOW WHY AND NOTED THAT THEY HAD NEVER DO
THEM ALL (B)(6)2014 BUT THE PATIENT HAD NOT HEARD BACK. THE PATIENT STATED THAT WERE THEY SUPPOSED TO BE DOIN
THAT ONE DOCTOR GOT THE NURSE CALL IN VICODIN. THE PATIENT STATED THAT COULD NOT DO IT NOW. THE PATIENT FURTH
THAT THEY COULD NOT TAKE ANY MORE PAIN. THE PATIENT NOTED THAT THEY WEREN'T TO THE EMERGENCY ROOM (ER) (B)(
GETTING IT AND THAT NOBODY WANTED TO LISTEN. IT WAS REVIEWED THAT IT WOULD BE BEST TO SPEAK WITH THE HEALTHC
NOT DO IT AND WOULD NOT CALL IN VICODIN. THE PATIENT NOTED THAT THEY DID NOT WANT TO BE ON PERCOCET ANYMOR
CONSTANTLY. THE PATIENT NOTED THAT WHEN THEY FELL ON THE FLOOR THEIR DID NOT CAREBUT DID STAY TO HELP THE PAT
OTHER DAY THEY FELL ON THE SIDE OF THE TOILET AND COULD NOT GET UP. IT WAS NOTED THAT THE PATIENT WAS SCREAMI
UP. THE PATIENT DECLINED A PHYSICIAN LISTING IN THIS CALL. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AV
ABOUT 50% ON HER RIGHT LEG, BUT NEVER VERY WELL FOR HER SPINE. � THE PATIENT NOTED IT �QUIT WORKING FOR HER
�ASKED IF SHE SHOULD HAVE IT REMOVED AND HE SAID NO. � ADDITIONAL INFORMATION STATED THE PATIENT �S �DEVI
SPINE� AND THAT SHE WAS �STILL HAVING PAIN.� IT WAS FURTHER REPORTED �IT WAS NO LONGER IN HER CHEST � AN
REPORT AND SHE WAS UNSURE �WHAT PIECE WAS WORKING, WHAT PIECE WASN �T WORKING, WAS IT IN HER LEG. � IT W
WITH HER HCP ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL NEEDED HELP AND
THERAPY. IT WAS NOTED THAT THE PATIENT DID NOT CURRENTLY HAVE A HEALTHCARE PROFESSIONAL (HCP) BUT NEEDED ON
STANDS STRAIGHT THE STIMULATION �IS BACK TO NORMAL�. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO ADJUST S
ACROSS THE CHEST. IT WAS NOTED THAT IT HAD ALWAYS BEEN GOING ACROSS THE PATIENT �S CHEST AREA. IT WAS REPORTE
NEUROSTIMULATOR SIDE. IT WAS REPORTED THAT AFTER THE PATIENT WOULD TURN UP THE STIMULATION IT WOULD START
WAS NEVER COMFORTABLE WHEN THE PATIENT SAT DOWN. ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT H
OF REPORT. IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION AND A LOSS OF THERAPEUTIC EFFECT. I
WAS NO STIMULATION AT ALL" IN HER LEGS AND HAD "SHOOTING STIMULATION" ACROSS HER CHEST. IT WAS NOTED THAT TH
DOWN, OR COUGHING EVEN WHEN SHE TURNED THE STIMULATION DOWN. IT WAS NOTED THAT THE "SHOOTING ACROSS HE
GROUPS. THERE WERE NO FALLS OR TRAUMA. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WIL
PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). . ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS STIMULATION
STIMULATION IN HER LEFT HIP AREA. IT WAS NOTED THAT THE MORE SHE WALKED THE MORE IT SEEMED THAT THE STIMULAT
2014 BUT SHE WAS STILL HAVING THE SAME ISSUES WITH STIMULATION GOING TO HER CHEST. IT WAS REPORTED THE PATIEN
RECOMMENDED THAT THE PATIENT CONTACT HER DOCTOR TO HAVE THE DEVICE COMPONENTS CHECKED WHILE STIMULATIO
TREAT PAIN THAT THE PATIENT HAD BEEN FEELING FOR THE PREVIOUS 3 MONTHS. IT WAS NOTED SHE WAS TAKING PERCOCET
PRIOR TO (B)(6). IT WAS NOTED SHE COULD NOT RECALL THE EXACT DATE. IT WAS REPORTED SHE FELL AND TORE LIGAMENTS
NO TESTING HAD BEEN DONE ON HER DEVICE AND NO X-RAYS HAD BEEN DONE TO LOOK AT LEAD WIRE PLACEMENT. IT WAS R
DID NOT HAVE A SPECIFIC TIME OR SCENARIO. IT WAS REPORTED THAT THE MEDTRONIC REPRESENTATIVE WAS NOTIFIED ABO
THE PATIENT'S PAIN COMPLAINT AT HER NEUROSTIMULATOR SITE THE WEEK OF (B)(6) 2014 AND THE PATIENT COULD NOT REC
TO HER.
PRODUCT ID 377745, LOT# N0039637, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT# N0039637, I
PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION PRODUCT ID 3708140 LOT# SERIA
PATIENT HAD MADE A FULL RECOVERY. (B)(4). IT WAS REPORTED THAT THE PATIENT WOKE UP FROM ANESTHESIA AND WAS U
HOSPITAL BLAMED THE DEVICE FOR THE ISSUE. THE IMPEDANCES AND DEVICE WERE CHECKED INTER-OPERATIVELY AND EVER
WEAKNESS ON THE LEFT SIDE OF HER BODY AND WAS WALKING WITH A CANE. IT WAS NOTED THAT NO ACTION WAS TAKEN A
EFFECTIVE THERAPY BUT THE ROOT CAUSE HAS NOT BEEN SPECIFICALLY DETERMINED BY FACILITY.
THE PT ((B)(6)) WAS NO LONGER RECEIVING EFFECTIVE COVERAGE IN HIS/HER RIGHT LEG. ON (B)(6) 2013, THE PHYSICIAN REV
COMPLETE. LATER THAT EVENING, IT WAS REPORTED, THE PT COULD NOT MOVE HIS/HER LEFT LEG. THE PT WAS BROUGHT BA
PT WAS STILL UNABLE TO MOVE HIS / HER LEFT LEG. IT WAS REPORTED ON (B)(6) 2013, THE PT HAD ALMOST FULLY RECOVERE
TRAUMA THAT OCCURRED IN 2009. AS A RESULT, THE PT HAS NEEDED A WHEELCHAIR OR CRUTCHES. IT WAS NOTED THE PT'S
(B)(4). THE COMPANY REPRESENTATIVE FOLLOWED UP WITH THE PATIENT. THE PATIENT STARTED FALLING FREQUENTLY IN (B)(
SHE SPENT FIVE DAYS AT A HOSPITAL AND THEN NINE DAYS IN REHABILITATION AT A SKILLED NURSING FACILITY. SHE LEFT THE
HERSELF TO AMBULATE. THE RECOVERY HAS BEEN SLOW BUT WAS GETTING THERE. IT WAS NOTED THAT SHE MISSED THE INS
(HCP) SENT THE EPIDURAL MASS THAT HAD GROWN AROUND THE LEAD AND WAS COMPRESSING THE PATIENT'S SPINE TO PAT
INFLAMMATION APPEARED MORE CHRONIC WITH ABUNDANT PLASMA CELL AND LYMPHOCYTES AND OCCASIONAL NEUTROP
ADJACENT TO THE INFLAMMATORY CELLS AND INFLAMED TISSUE. NO EVIDENCE OF ATYPIA OR MALIGNANCY WAS SEEN. SPEC
OUTCOME WAS NOT PROVIDED, BUT PERMISSION WAS GIVEN TO DIRECTLY CONTACT THE PATIENT BY THE HCP. ADDITIONAL IN
(SERIAL NUMBER: (B)(4)) FOUND NO SIGNIFICANT ANOMALY. PRODUCT WAS FUNCTIONALLY OKAY. ANALYSIS OF THE EXTENSIO
NUMBER: (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE LEAD (SERIAL NUMBER: (B)(4)) FOUND NO SIGNIFICANT ANOMALY. T
PATIENT'S REQUEST. BATTERY DEPLETION WAS MARKED AS NOT NORMAL. THE CAUSE OF THE EXPLANT WAS BOTH DEVICE AN
HAD STARTED EXPERIENCING NUMBNESS IN LEGS AND HIPS WHICH SPREAD UP TO WAIST. MYELOGRAM WAS PERFORMED, DU
SPINE WAS DECOMPRESSED IN T 8-9 THORACIC SPINAL CORD. THE LEAD WAS SENT TO PATHOLOGY ANALYSIS ALONG WITH SU
REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE
IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT
SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE
THE PT HAD TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED A SHARP PAIN IN THEIR BACK
WERE IMPLANTED AT T8 LOW-TO-MODERATE RESISTANCE WHILE IMPLANTING THE RIGHT LEAD DUE TO SCAR TISSUE. THE PH
THE PT MAY HAVE AN EPIDURAL HEMATOMA. THE PT WAS THEN TAKEN TO THE ER. THE PHYSICIAN INDICATED THE PT DID NO
(B)(4). PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B
REPORTED THAT THE PATIENT RECEIVED ASSISTANCE AND HER CONCERNS RESOLVED. ADDITIONAL INFORMATION RECEIVED R
AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IT WAS REPORTED THAT THE PATIENT SUSTAINED A BACK INJURY "ABO
SINCE THEN, THE PATIENT REPORTEDLY HAD BEEN IN "CONSTANT PAIN" AND HAD "A TON OF MUSCLE SPASMS FOR A FEW WE
THE PAIN WAS NEAR THE PATIENT'S INS AND THE INS HAD BEEN RECHARGING "VERY SLOWLY" SINCE HER INJURY. IT WAS NOTE
HERNIATED DISC. IT WAS NOTED THAT THE PAIN DOCTOR DID NOT SEE ANYTHING "OUT OF THE ORDINARY" ON THE X-RAY. A S
IT WAS REPORTED THE PATIENT COMPLAINED OF A RANDOM BURNING SENSATION AT HIS IPG SITE WHICH WAS NOT ASSOCIA
STATED HIS IPG SITE IS PAINFUL AND FEELS "LIKE A BRUISE." FOLLOW-UP IDENTIFIED THE PHYSICIAN NOTED THE IPG MAY BE S
SEE IF IT WORSENS AND STATED A REVISION PROCEDURE MIGHT BE NECESSARY. FURTHER FOLLOW-UP INDICATED THE PATIEN
IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM
MEDICAL HISTORY.
ADDITIONAL INFORMATION RECEIVED OVER FIVE MONTHS LATER REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE M
NOTABLY MORE QUICKLY AND FLUIDLY THAN THE LAST TIME THE MANUFACTURER'S REPRESENTATIVE REPORTEDLY SAW HER.
ABDOMEN DOWN TO FEET, BUT AT THE TIME OF REPORT THE NUMBNESS WAS MORE CONCENTRATED IN THE MID-THIGH ARE
THE MANUFACTURER'S REPRESENTATIVE SET UP THE DEVICE COVERING THE PAINFUL AREAS WITH FOUR DIFFERENT GROUPS.
AMBULATE AROUND THE OFFICE TO ADJUST THE STIMULATOR FOR "UPRIGHT AND MOBILE," THE PATIENT NOTABLY COULD NO
SPASMS LASTING ABOUT 30 SECONDS. THE MANUFACTURER'S REPRESENTATIVE REPORTEDLY TURNED THE STIMULATION OFF
AMBULATION. THE PATIENT WAS TO TRY GROUPS AND SET UP STRENGTH FOR LYING POSITIONS AT HOME. THE PATIENT WAS R
INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVE
THE PREVIOUS DAY AT THE REHABILITATION CLINIC. THE PATIENT WAS STILL IN A WHEEL CHAIR. THE PATIENT REPORTED HAVIN
BUT STILL COULD NOT AMBULATE WITHOUT PHYSICAL ASSISTANCE. (B)(4). ADDITIONAL INFORMATION REPORTED INDICATED
TOO FAR. IT WAS STATED THAT "NUMBNESS CAME AND WENT," REFERRING TO PATIENT'S LEGS. THE PATIENT HAD NOT BEEN U
REPORTER WAS BRINGING THE FEELINGS BACK. IT WAS STATED SHE MIGHT NOT BE READY TO START USING THE DEVICE AT TH
WITH HER DEVICE WHEN SHE HAD STOPPED USING IT BECAUSE SHE DIDN'T FEEL LIKE IT WAS HELPING HER AS MUCH AS IT DID
SAID IT WAS OK TO ACTIVATE THE PATIENT'S STIMULATOR. THE REPRESENTATIVE WAS SCHEDULED TO MEET WITH THE PATIEN
REPORTED INDICATED THAT THE PATIENT WALKED WITH EFFORT USING 2 CANES. SHE WAS STILL COMING TO GRIPS WITH HER
PADS TO HELP WITH MAINTAINING SIGNAL. ADDITIONAL INFORMATION INDICATED THE PATIENT HAD BEEN REPROGRAMMED
TO THE EXAM TABLE, SHE TRANSFERRED WITH MORE EASE. THE PATIENT STILL DID NOT HAVE STEADY CONTROL OF BILATERAL
GOOD.� THE PATIENT COULD FEEL GENTLE TOUCHES ON BILATERAL LOWER EXTREMITIES TO THE FEET. THE PATIENT STATED H
CONTROL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. . CONCOMITANT MEDICAL PRODU
RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). THE INITIAL MDR WAS FILED
THE NIGHT THE PATIENT WAS IMPLANTED WITH A SURGICAL PADDLE LEAD THE PATIENT NOTICED ABDOMINAL PAIN AND ONE
LEGS AND SHE WAS UNABLE TO VOID. THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) BELIEVED THERE WAS PRESSURE ON
PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD YET TO BE ACTIVATED AT THE TIME OF THE EVENT AND WAS GOING T
DATE OF THIS REPORT; A FOLLOW UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATIO
WALK WITHOUT ASSISTANCE AND CONTINUED TO HAVE NUMBNESS IN HER LEGS. THE PHYSICIAN INDICATED SHE MAY STILL H
SAY SHE WAS GETTING SOME GLIMPSES OF FEELING BACK IN HER FEET AND SOME FEELINGS OF PAIN IN HER HIPS. THE NEURO
AT THE PHYSICIAN'S OFFICE WHERE THE PATIENT WAS SET UP WITH 4 PROGRAMS WHICH RESULTED IN GOOD COVERAGE FOR
WHICH WAS MORE PAINFUL IF THEY BUMPED HARDER. WHEN OBSERVING THE PATIENT MOVE FROM THEIR WHEELCHAIR TO
DIFFICULTY. THE PATIENT STATED THAT THEY COULD NOT TELL IF THEIR FEET WERE UNDER THEM AND HAD TO LOOK TO SEE IF
THEIR LEGS WERE TOGETHER AND HAD TO BE CAREFUL NOT TO LET ONE LEG LAG BEHIND THE OTHER. IF ADDITIONAL INFORM
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02109. IT WAS REPORTED THE PT FELT SHARP STIMULATION IN HER L
CONTACTS. AN X-RAY CONCLUDED BOTH OF THE PT'S LEADS HAD MIGRATED. THE PT REPORTED SHE FALLS FREQUENTLY AND I
POSSIBLE LEAD REVISION SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINI
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-02108. IT WAS REPORTED THE PT FELT SHARP STIMULATION IN HER L
CONTACTS. AN X-RAY CONCLUDED BOTH OF THE PT'S LEADS HAD MIGRATED. THE PT REPORTED SHE FALLS FREQUENTLY AND I
POSSIBLE LEAD REVISION SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINI
ADDITIONAL WAS RECEIVED THAT THE PHYSICIAN SAID THERE WERE NO PARALYTIC SYMPTOMS. THE PATIENT WAS EXPERIENC
VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. SC-8216-
THE PADDLE LEAD. IN ADDITION, ELECTRODE #8 IS DISLODGED AND MISSING FROM THE PADDLE. THE DAMAGE TO THE DEVIC
THE MISSING CONTACT FROM THE PADDLE LEAD WAS REMOVED AND WAS NOT LEFT INSIDE THE PATIENT. ADDITIONAL INFOR
INVOLVED: MODEL #: SC-1110-02 SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). A REPORT
ALLERGIC REACTION. IT IS UNKNOWN AT THIS TIME WHAT WAS THE CAUSE OF THE ALLERGIC REACTION. THE PATIENT WILL BE
THE PT'S IPG AND LEADS WERE EXPLANTED AD REPLACED (REF MFR REPORT#: 1627487-2013-12075 AND 1627487-2013-1207
WALKER AND WHEELCHAIR.
THE PATIENT RECEIVED TWO LEADS (FROM THE SAME LOT) AS PART OF HIS SCS TRIAL SYSTEM. IT WAS REPORTED THE PATIENT
HAVE A HEMATOMA FROM T-4 TO T-8. THE PATIENT DID NOT REPORT ANY RESIDUAL PARALYSIS OR WEAKNESS. THE PHYSICIAN
IT WAS REPORTED, THE PATIENT BEGAN EXPERIENCING PARALYSIS OF HIS LEGS LATE ON (B)(6) 2012. THE PATIENT WAS INSTRU
THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT WAS KEPT IN THE HOSPITAL FOR OBSERVATION. FOLLOW UP REGARDING T
PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE
PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), IM
PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4). (B)(4). IT WAS REPORTED T
WAS NEARING DEPLETION. THE PATIENT NOTED THE HEALTH CARE PROVIDER (HCP) ADVISED THEM "THAT ONE PART OF THEIR
HAVE TO PERFORM A LAMINECTOMY IN ORDER TO TRY TO RETRIEVE THE EXISTING PIECE. IT WAS ALSO REPORTED WHEN THE
THE PATIENT REGAINED MOVEMENT AGAIN. THE PATIENT STATED THE HCP SAID "THAT MAYBE WHEN THE LEAD WAS ATTEMP
HAD A BIG NICK IN IT." AN INCH BELOW THE SLICE OR NICK THE WIRE WAS BARE, SMASHED, AND HAD A CUT IN IT. IT WAS NO
PROCEDURE AND CUT THE TAILS OF THE LEAD AND LEFT THE PADDLE PORTION IMPLANTED. IT WAS NOTED THE HCP "TUGGED
ISSUES, INS WAS NEAR END OF LIFE, AND THE PATIENT ALSO NEVER HAD STIMULATION COVERAGE FROM THE BEGINNING. IT W
FIRST ATTEMPT TO GET NORMAL LEAD IN, THE HCP HAD A HARD TIME." IT WAS REPORTED THE PATIENT NOTICED PARALYSIS F
10-15 MINUTES. IT WAS ALSO NOTED THE NURSE MAY HAVE THOUGHT "THE SPINE SUFFERED A CONCUSSION DURING THE TU
RESOLVE. PATIENT STATED "THEY STARTED MOVING TOES TO WHICH THEY ADDED ICE TO THEIR LEGS WHICH FELT VERY HOT TO
THE PROCEDURE. IT WAS NOTED THE PATIENT HAD CONCERNS THAT THEIR LEAD WAS EITHER "BACKWARDS OR HAD FLIPPED
OUTSIDE INSULATION." THE PATIENT COULD SEE IT ON THE DEVICES THAT WERE REMOVED. IT WAS NOTED THE HCP SUGGEST
POCKET AND THE INVASIVENESS OF THE PROCEDURE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVA
RECEIVED STATED THE PADDLE LEAD HAD ADHERED TO THE SURROUNDING TISSUE CAUSING IT TO BE DIFFICULT TO BE REMOV
DISCUSSED IF A LEVEL II LAMINECTOMY WILL BE DONE TO REMOVE THE PADDLE PORTION, BUT NOTHING HAD BEEN SCHEDUL
TIME CAUSING PARTIAL LIMITED MOBILITY TO THE PATIENT'S LEGS." IT WAS STATED THAT THE PARTIAL PARALYSIS "RESOLVED
SEEN POSTOPERATIVELY. IT WAS STATED THAT THE "SMASH, NICK MARK BELOW THE LEAD IN THE OUTSIDE INSULATION, HAPP
PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PR
ACUTE PAIN, MOTOR WEAKNESS, AND NUMBNESS DOWN THE PATIENT'S LEG. IT WAS NOTED THE PATIENT WAS THREE MONT
SITUATION AND WAS TYPICALLY USING A WALKER OR A WHEELCHAIR. IT WAS NOTED STIMULATION WAS ON 24 HOURS A DAY
PREGNANCY. SEVERAL MONTHS LATER IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN "WORK
THEIR LEG BUT ONLY FROM THEIR KNEE AND UP. X-RAY WAS TAKEN AND LEADS WERE AT T10 INSTEAD OF T8 "WHICH WOULD
BIRTH THREE MONTHS PRIOR THE PATIENT HAD NOT BEEN ABLE TO USE THEIR INS. WHEN THE PATIENT ATTEMPTED TO USE T
NO LONGER COVERED. THE PATIENT HAD BEEN USING THE EMERGENCY ROOM FOR PAIN AND REFLEX SYMPATHETIC DYSTROP
HAD BEEN USING INTRAVENOUS KETAMINE TO HELP WITH THE PAIN. IT WAS NOTED SINCE THE PATIENT GOT AN EPIDURAL AN
CHARGING DURING PREGNANCY BUT HAD SEEN A CALL DOCTOR SCREEN 7 MONTHS PRIOR. PATIENT HAD NOTIFIED THEIR DO
HAD NOT CHARGED SINCE. IT WAS ALSO NOTED THERE WERE COUPLING AND OR COMMUNICATION ISSUES AND AN INS OVER
SUCCESSFUL CHARGING SESSION WAS 6 TO 12 MONTHS PRIOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS N
PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF A PERMANENT SCS SYSTEM. IT WAS REPORTED, THE PHYSICIAN WAS U
BLANK WAS USED TO TEST LEAD PLACEMENT. THE PATIENT REPORTED PARTIAL PARALYSIS IN BOTH LEGS POSTOPERATIVE. THE
CORD. IT WAS REPORTED, THE PATIENT HAD IMPROVEMENT OF HER QUADRICEPS PARALYSIS POSTOPERATIVE BUT THE PHYSIC
(B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED A 'PARAPLEGIC REACTION (HEMATOMA)' POST OPERATIVELY AND T
PHYSICIAN DID NOT KNOW THE CAUSE OF THE EVENT AND WAS ALSO NOTED THAT NOTHING WRONG DURING THE PROCEDU
PHYSICIAN FELT THE LARGER LEAD INCREASED THE HEMATOMA RISK. IN ADDITION, IT WAS REPORTED THAT THIS WAS THE FIR
AGAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. PRODUCT ID 39565-30, LOT# 020638
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESC
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO MEDICAL COMPLICATIONS FOLLO
PHYSICIAN BELIEVED THAT THE EVENT WAS PROCEDURE RELATED. THE PATIENT WAS RE-IMPLANTED FOR THE SAME INDICATIO
A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT ABLE TO WALK AND HAS BEEN IN A WHEELCHAIR SINCE THE SCS IMPLA
WAS ALREADY DISABLED PRIOR TO IMPLANT OF THE SCS SYSTEM. BASED ON THE PHYSICIAN'S ASSESSMENT, THE SYMPTOMS W
EVENT: MODEL #: 8216-50 SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN (B)(6) 2012 THE PATIENT WAS HAVING SEVERE SPASMS COVERING T
WAS NOTED THAT AFTER THE PATIENT TURNED OFF THE SYSTEM COMPLETELY AND LEFT IT OFF, THE SPASMS STOPPED. A CT S
STATED THAT THE PATIENT HAD A "LONG, VIOLENT" BUS RIDE AT THE END OF (B)(6) 2012 WITH "A GOOD LOT OF BOUNCING A
IN (B)(6) 2012 "LITTLE EXERCISES" WOULD CAUSE A "JERK" OF THE WHOLE LEG. ON (B)(6) 2012 COMPLETE SPASMS OF THE BA
SCIATIC NERVES IN THE LEGS AND FEET. THE REPORTER STATED THAT THE PATIENT FELT THAT SOME OF THE STIMULATION HAD
PATIENT HAD SPASMS ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT HAD NEUROPATHY AND PAIN IN HER BACK. IT WA
"INAPPROPRIATELY IDENTIFIED" THE SPASMS AS SEIZURE-LIKE MYOCLONIC EPISODES WHEN THEY STARTED. THE REPORTER ST
EVENTS AS OVERSTIMULATION OF THE COVERED AREAS OF HER DEVICE SYSTEM. A FOLLOW-UP REPORT WILL BE MADE IF ADD
HER THERAPY BUT HAS BEEN WORKING WITH HER DOCTOR AND MANUFACTURER REPRESENTATIVE SINCE (B)(6) 2012. IT WAS
PAIN THEN SHE COULD HANDLE' AND PHYSICALLY BROUGHT HER WHEEL-BOUND LEGS UP TO HER CHEST. (B)(4). ADDITIONAL
THEM TO HAVE STRONG MYOCLONIC SEIZURES. IT WAS NOTED THAT THE PATIENT BEGAN HAVING SEIZURES 2 TIMES A DAY, EV
OTHER INFORMATION IN THIS CALL HAS BEEN PREVIOUSLY RECORDED AND REPORTED IN THIS EVENT AND EVENTS (B)(4), (B)(
THE SPASMS WENT AWAY WHEN STIMULATION WAS TURNED OFF. A DEVICE INTERROGATION OF (B)(6) SHOWED IMPEDANCE
00161). . PRODUCT ID: 749851, SERIAL#: (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION; PRODUCT ID: 7435, SER
TYPE: LEAD; PRODUCT ID: 3550-09, LOT#: LA7205, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: ACCESSORY. (B)(4).
REPORTED THE PATIENT (B)(6) WAS ADMITTED TO THE HOSPITAL WITH SUDDEN ONSET PARALYSIS TO BOTH LEGS. DIAGNOSTIC
SCS SYSTEM. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT IS IMPROVING. ADDITIONAL SURGICAL INTERVENTION WAS
PATIENT WAS WALKING WITHOUT DIFFICULTY TWO DAYS FOLLOWING THE PROCEDURE. THE PATIENT WAS REPROGRAMMED A
IT WAS REPORTED THE PT (B)(6) UNDERWENT SURGERY TO REVISE THE PLACEMENT OF THE LEAD. THE PT WAS DISCHARGED F
INTERVENTION WAS UNDERTAKEN ON (B)(6) 2012 AND A HEMATOMA WAS DISCOVERED. THE PHYSICIAN DECIDED TO EXPLAN
DESCRIBED IN THE EVENT DETAILS, THE CUSTOMER COMPLAINT CANNOT BE ANALYZED THROUGH PRODUCT ANALYSIS ALONE
THE CHANNELS' RESISTANCE; ALL CHANNELS PASSED. INTER-CHANNEL CONDUCTIVITY TESTING DID NOT FIND ANY SHORTS. NO
RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTOR
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8216-70, SERIAL: (B)(4) DESCRIPT
REPORT WAS RECEIVED THAT THE PATIENT HAD AN EXPLANT OF THE SCS SYSTEM THREE HOURS FOLLOWING IMPLANT DUE TO
PATIENT IS REPORTEDLY DOING WELL AFTER THE EXPLANT.
IT WAS REPORTED THAT PATIENT "FELL DOWN MULTIPLE FLIGHTS OF STAIRS AND WAS PARALYZED IN THE LOWER EXTREMITY."
NORMAL. IT WAS NOTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AS THE TIME OF THE REPORT. IT WAS NO
CORRECT CERVICAL LOCATION, BUT WAS UNABLE TO FEEL STIMULATION IN HIS LOWER EXTREMITY, WHERE THE PATIENT WAS
MORNING OF THE REPORT. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS TURNED DOWN TO 0 V AND OFF. ADDITIONAL INF
"WANTED TO MAKE SURE THAT THE DEVICE WORKED AND IF THERE WERE ANY MALFUNCTIONS." NO INTERVENTIONS WERE S
ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE MANUFACTURER'S REPRESENTATIVE WAS ASKED TO CHECK (BY TH
THE INS WAS TURNED OFF WHILE THE PATIENT WAS IN THE HOSPITAL. IT WAS ALSO NOTED THAT THE PATIENT WAS INSTRUCT
TO THE CAUSE AND DATE OF THE PATIENT'S FALL AND ITS RELATIONSHIP TO THE INS SYSTEM. IF ADDITIONAL INFORMATION IS
PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B
PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4
LOT# V002755, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4). IT WAS REPORTED THAT THE PATIENT HAD A SURGING S
ANYMORE, AS IT WAS NOT SERVING THE PURPOSE OF CONTROLLING HER PAIN, AND HAD NOT USED IT IN OVER A YEAR. IF TH
POINT WHERE IT BECAME VERY UNCOMFORTABLE DUE TO POSITIONAL MOVEMENT AND TO WHERE SHE WAS TURNING IT OF
PATIENT WAS STILL CONTINUING TO HAVE PAIN IN HER LEFT LEG, TOES AND BACK. BEFORE IMPLANT, SHE WAS HAVING PAIN D
THE MRI PRIOR TO THE IMPLANT, THEY SAW THE DAMAGE ON THAT LEFT SIDE WHERE NERVES WERE BEING PINCHED AND TH
EVENTUALLY THAT HELPED FOR A WHILE AND ALL THE TIME THE RIGHT SIDE KEPT GETTING WORSE. THE PATIENT STATED THAT
TO HER LEFT SIDE ISSUES. PATIENT STATES SHE KEPT COMPLAINING ABOUT HER RIGHT SIDE. PATIENT STATES SHE CAN'T REMEM
SURGERY AGAIN BUT THERE WAS ONLY A POTENTIAL 50/50 CHANCE TO RELIEVE THE PAIN, WHICH WAS THE REASON WHY SH
TELLING HER THAT IT IS DUE TO SCAR TISSUE BUILDUP AND IT DIDN'T SEEM TO MAKE SENSE TO DO SURGERY AGAIN FOR THIS
WAS STILL HAVING MUSCLE SPASMS IN THE UPPER PART OF HER BACK TOO. THE LOWER PART OF HER BACK WHERE HER BUTT
THE PATIENT WAS REPROGRAMMED ONCE, BUT THAT WAS A LONG TIME AGO. THE PATIENT HAD TINGLING IN HER HANDS, FE
PATIENT WAS HAVING COMPRESSION ON HER NERVES IN HER NECK AND HAD TO PERFORM EMERGENCY SURGERY TO REMOV
DEVICE PLAYED ANY ROLE IN THE TIA.] THE SURGERY WAS FOR SEPARATION. PATIENT STATES SHE WAS VERY UPSET BECAUSE S
ADDITIONAL INFORMATION RECEIVED REPORTED PARALYSIS. THE REPORTER STATED THAT THE PATIENT NO LONGER HAD A DE
EXTREMITIES. THE REPORTER STATED THAT THE SYMPTOMS OCCURRED FOLLOWING LEAD REPLACEMENT. IT WAS REPORTED T
PROVIDER TOOK HER BACK INTO SURGERY AND REMOVED THE WHOLE SYSTEM. THE REPORTER STATED THAT THE PATIENT WA
PATIENT WAS IN THE HOSPITAL FOR FIVE DAYS AFTER THE SURGERY BEFORE GOING TO THE REHAB CENTER. IT WAS REPORTED
REPORTER STATED THAT "OBVIOUSLY SOMETHING WENT ON NEAR THE SPINAL CORD AND IT RECEIVED SOME DAMAGE" AND
AVAILABLE. PRODUCT ID NEU_SILICONEANCHOR, PRODUCT TYPE ACCESSORY; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANT
SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF T
PATIENT STILL HAD WEAKNESS IN HER LEGS, BUT WAS ABLE TO WALK WITH ASSISTANCE. IT WAS REPORTED THE PATIENT'S PER
SURGICAL LEAD WAS PLACED THE PATIENT HAD A LOT OF SCAR TISSUE. WHEN THE PATIENT WAS AWOKEN FROM GENERAL AN
PATIENT TO RECEIVE A STEROID DOSING AND SHE WAITED APPROXIMATELY AN HOUR FOR THE FULL EFFECT. THERE WAS NOT
REVEALED A SPINAL CORD CONTUSION; IT WAS THOUGH THE CONTUSION MAY HAVE OCCURRED WHEN THE PHYSICIAN WAS
REPORTED THE PATIENT'S LEGS REMAINED WEAK. IT WAS ALSO NOTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS
SIGNIFICANT ANOMALY. ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE ANCHOR FOUND N
THE PHYSICIANS ASSESSMENT OF THE PARALYSIS HAS NOT BEEN DETERMINED AT THIS TIME. ADDITIONAL SUSPECT MEDICAL
STYLET - 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY
UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVES THE HEMATOMA IS DEVICE RELATED. THE PATIENT'S HUSBAN
UNDERGOING REHAB AS THE SYMPTOMS HAVE NOT RESOLVED.
(B)(4). ZIMMERMAN, A., RAUCK, R. L. THE DELAYED APPEARANCE OF NEUROLOGICAL SIGNS IN INTRATHECAL GRANULOMA WA
PAIN. 2012;12(7):561-569. DOI: 1 0.1111/J.1533-2500.2012.00540.X. SUMMARY: INTRATHECAL PUMP THERAPY (ITP) HAS BECO
FOR THE FAILED BACK PAIN POPULATION. INFLAMMATORY MASS OR GRANULOMA IS A COMPLICATION THAT IS CONSIDERED "
IS BEING TREATED. THE CASE SERIES REPORTED HERE ILLUSTRATES 4 CASES OF INFLAMMATORY MASS. ONE PATIENT PRESENTE
CASES PRESENTED ILLUSTRATE THE NEED FOR BROADER EDUCATION OF INFLAMMATORY MASS AMONG NONPAIN SPECIALIST
OF PATIENTS WHO PRESENT WITH PARALYSIS AS WELL AS THE NEED FOR REGULAR SCREENING OF ITP PATIENTS. REPORTED EV
WITH CONTINUED REPORTS OF PAIN. INTRATHECAL PUMP TRIAL WAS UNDERTAKEN IN (B)(6) 2003 WITH PRESERVATIVE-FREE
TIME OF SCS REMOVAL, THERE WAS SOME DIFFICULTY REMOVING 1 LEAD, AND THE TIP REMAINED IN THE EPIDURAL SPACE A
INFORMATION IS RECEIVED. SEE LITERATURE ARTICLE ATTACHED TO MANUFACTURER REPORT 3007566237-2012-02433. PROD
DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPO
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT THE CAUSE OF THE EVENT WAS TH
ACCORDINGLY. THE SPINAL CORD STIMULATION TRAIL WAS REMOVED IN THE CLINIC AND NO FUTURE INTERVENTIONS HAVE T
IT WAS REPORTED THAT AFTER A TRIAL SURGERY THE PATIENT HAD A TERRIBLE PAIN IN HER LEFT FOOT AND 6 INCHES UP HER
DOCTOR SAID HE MIGHT HAVE BRUISED A NERVE AND SHOULD HEAL WITHIN A MONTH. THE PATIENT GOT THE TRIAL TO TREA
EXCRUCIATING PAIN, FOOT DROP, AND PARALYSIS IN THE LEFT FOOT. THE PATIENT WAS ON COUMADIN. A FOLLOW-UP REPOR
2012, PRODUCT TYPE LEAD. (B)(4).
FOLLOW UP INFORMATION REPORTED THE PATIENT WAS SLOWLY RECOVERING AND THE HEALTH CARE PROVIDER SEEMED CO
EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4). IT WAS REPORTED THAT TWO DAYS AFTER LEAD IMPLANTATION, THE PA
WAS RECOVERING SENSATIONS IN THE TWO LEGS INCLUDING FEET AND THIGHS, AND WAS TO BE SENT TO A REHABILITATION
PRODUCT ID, 7495-51 LOT# SERIAL# (B)(4), IMPLANTED: 2001 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERI
NEUROSTIMULATOR PRODUCT ID, 3550-09 LOT# LB8172, IMPLANTED: 2004 (B)(6), EXPLANTED: 2008 (B)(6), PRODUCT TYPE AC
THERAPEUTIC EFFECT. PATIENT WAS IN "A LOT OF PAIN" AND "STRONG STIMULATION SENSATION" AT THE SCAR LOCATED ON S
PAST 6 TO 8 MONTHS. PATIENT USED TO FEEL STIMULATION UP TO SHOULDERS AND LEGS AND NOW DID NOT FEEL THE STIMU
WHEELCHAIR OR USED CRUTCHES. DURING PHYSICIAN APPOINTMENT ON (B)(6) 2012, IT WAS DISCUSSED A POSSIBILITY OF A
EXPERIENCED PARALYSIS IN HER LOWER EXTREMITIES AFTER SHE UNDERWENT A PERMANENT IMPLANT PROCEDURE. AN MR
ONCE THE SCS SYSTEM WAS REMOVED.
IT WAS REPORTED THAT PATIENT FELL AND WAS HOSPITALIZED. PATIENT HAD PREVIOUS STROKE HISTORY PRIOR TO IMPLANT
TIME IF FALL WAS RELATED TO TRIAL STIMULATION. PATIENT HAD NOT RECEIVED FULL INTERSTIMULATOR IMPLANT YET, AND I
INFORMATION BECOMES AVAILABLE. (B)(4).
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-1626. IT WAS REPORTED THE PT DEVELOPED A HEMATOMA WHILE IN
IN HIS LEFT LEG AT THIS POINT. THE PT WAS WHEELCHAIR BOUND DUE TO PAIN AND SPASMS IN HIS RIGHT LEG AND HAD A GR
IDENTIFIED THE PT HAS NO FEELING IN HIS LEGS AND IS CURRENTLY IN A REHAB FACILITY. SJM HAS LIMITED INFO RELATED TO
TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-1627. IT WAS REPORTED THE PT DEVELOPED A HEMATOMA WHILE IN
IN HIS LEFT LEG AT THIS POINT. THE PT WAS WHEELCHAIR BOUND DUE TO PAIN AND SPASMS IN HIS RIGHT LEG AND HAD A GR
IDENTIFIED THE PT HAS NO FEELING IN HIS LEGS AND IS CURRENTLY IN A REHAB FACILITY. SJM HAS LIMITED INFO RELATED TO
TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT FELT STIMULATION IN THE W
UNTIL 2011 WHEN THE PATIENT INJURED HER BACK AGAIN; THE PATIENT'S L3 AND L4 SPINAL VERTEBRAE WERE OPERATED ON
BATTERIES AND GOT IT WORKING." THE STIMULATION "SEEMED LIKE IT'S ON ONLY HALF OF THE AREA." THE PATIENT TURNED
ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. (B)(4). PRODU
(4), IMPLANTED: (B)(6) 2002, EXPLANTED: PRODUCT TYPE: EXTENSION PRODUCT ID: 7435, LOT#: SERIAL#: (B)(4), IMPLANTED
EXPLANTED: PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT#: J0210015V, SERIAL#: IMPLANTED: (B)(6) 2002, EXPLANTED
PATIENT FROM A WHEELCHAIR TO A COMMODE WHEN HE FELL. SHE FELL WITH HIM AND THEN JERKED HIM BACK UP. IN ADD
DUE TO PATIENT REQUEST. THE STIMULATOR HAD NOT BEEN USED ON A REGULAR BASIS, AND HAD NOT BEEN USED RECENTLY
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PAIN WAS DUE TO THE PATIENT'S WHEELCHAIR WHICH WAS APPLYING C
EXTENSIONS AND REPOSITIONED THE IPG FROM HIS BUTTOCKS TO THE LEFT ABDOMEN AREA. THE PATIENT WAS REPORTEDLY
POCKET SITE.
IT WAS REPORTED THAT THE PATIENT'S INS WAS INITIALLY ON THE SHOULDER, BUT WAS REVISED TO THE SIDE. THE REASON F
'CRACKS', BACK 'SNAPS' AND PAIN FOR THREE YEARS. THE PATIENT REPORTED THAT SHE COULD NOT USE THE DEVICE OR TURN
SYSTEM SETUP SCREEN. IT WAS REPORTED THAT THE DEVICE WAS IN OVERDISCHARGE, AND THE PATIENT REFUSED TO LET A M
BUT HER PHYSICIAN WOULD NOT EXPLANT IT DUE TO THE RISK. IT WAS LATER REPORTED THAT THE PHYSICIAN AGREED TO EX
RESTART THE DEVICE SCHEDULED FOR (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS
GOING TO THE ER FOR PAIN. A NEW APPOINTMENT WAS SCHEDULED FOR OCTOBER 17TH. . PRODUCT ID 3778-45, SERIAL# (B
37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4)
HADN'T WORKED FOR TWO YEARS, AND COULD NOT BE INTERROGATED. IT WAS NOTED THAT THE PATIENT HAD JUMP STARTE
WOULDN'T TREAT HER. AFTER VARIOUS ATTEMPTS, THE PATIENT COULD NOT FIND AN MD WHO WOULD DO EITHER SURGERY
THE PATIENT STATED THAT THE BATTERY SITE HURT, BUT NO ONE WOULD TOUCH HER.
DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2012-00571. IT WAS REPORTED, THE PT WAS ADMITTED TO ICU A DAY AFT
THE PT REPORTEDLY CONTRACTED (B)(6) AND PNEUMONIA. THE PT REPORTS, SHE IS CURRENTLY CONFINED TO A WHEELCHAI
ACTION LETTERS TO THE PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INC
HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEW
BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S
PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2012-00561. IT WAS REPORTED THE PT WAS ADMITTED TO ICU A DAY AFT
PT REPORTEDLY CONTRACTED (B)(6) AND PNEUMONIA. THE PT REPORTS SHE IS CURRENTLY CONFINED TO A WHEELCHAIR AN
LETTERS TO THE PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN
AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WER
DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S ME
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN SCS EXPLANT DUE TO A FULL BODY PARALYSIS. THE PHYSICIAN I
WAS NO MALFUNCTION SUSPECTED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. A REPORT WAS
PHYSICIAN PERFORMED A CT SCAN WHICH SHOWED NARROWING AT THE LEAD SITE BUT WAS INCONCLUSIVE DUE TO IMAGE
WAS UNSUCCESSFUL. THE PHYSICIAN THEN EXPLANTED THE REMAINING DEVICES IN ORDER TO PERFORM AN MRI. THE MRI S
TISSUE THAT HAD FORMED AROUND THE LEAD. THE PATIENT HAS BEGUN TO REGAIN SOME MOTOR FUNCTION. THE REST OF T
SERIAL: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM, MODEL: SC-1110-02, SERIAL: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE
CHARACTERISTICS. DAMAGE TO THE LEAD AND EXTENSIONS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CO
(B)(4). LEAD: MODEL 3898-33, LOT# LB4325, IMPLANTED: 2003 (B)(6), EXPLANTED: NA; EXTENSION: MODEL 747151, SERIAL# (
FELL OUT OF A TRUCK. THE PATIENT BELIEVED THAT THE LEAD WAS MOVED OR PUSHED DURING THE FALL. AFTER THE FALL, TH
AND HANDS, AND A LOSS OF FEELING IN HER LEGS AND ARMS. THE PATIENT UNDERWENT A CT MYELOGRAM WHICH SHOWED
HER ARMS, LEGS, HIPS AND KNEES. IT WAS NOTED THAT THE PATIENT RECENTLY HAD THE DEVICE CHECKED BY A PHYSICIAN AN
WRONG AREAS. IT WAS NOTED THAT THE PATIENT ALSO HAD PROBLEMS WITH HER ESOPHAGUS AND HAD 1ST STAGES OF CAN
THEY COULDN'T REMOVE THE DEVICE COMPONENTS BECAUSE, IT MAY CAUSES PARALYSIS. ADDITIONAL INFORMATION HAS B
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-1110-02, SERIAL: (B)(4), DESCRIPT
DUE TO WEAKNESS AND PARALYSIS IN HER LEGS. THE PHYSICIAN IS UNSURE OF THE CAUSE OF THE REPORTED EVENT. THE PAT
INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. TH
TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE.
IT WAS REPORTED THAT SINCE SURGERY THE PATIENT HAD EXPERIENCED TEMPORARY PARALYSIS. THE PATIENT WAS IN THE HO
REHABILITATION FOR 4.5 WEEKS, RATHER THAN 4.5 DAYS. THE PATIENT WAS HOME THE DATE OF REPORT, BUT HAD FELL TRYIN
DEVICE ADJUSTMENT 3-4 WEEKS AGO BY A MANUFACTURER'S REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT FOR (B)
AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. (B
IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER; PRODUCT ID 37744, LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED:
APPOINTMENT ON (B)(6) 2012. IT WAS CLARIFIED THAT THE PATIENT WAS IN REHABILITATION FOR 4.5 WEEKS. IT WAS ALSO CL
STIMULATION WHERE SHE WAS FEELING IT. THE PATIENT WAS NOT GETTING PAIN RELIEF FOR THE PRIOR 2 WEEKS. THE PATIEN
STIMULATION, BUT IT WASN'T CONTROLLING THE PAIN. THE PATIENT WASN'T SURE WHAT HAD CAUSED THE "ISSUE OF THE NE
PEDALING. THREE WEEKS LATER, IT WAS REPORTED THAT AN IMPEDANCE CHECK FOUND NORMAL IMPEDANCES. A REPROGRA
RECEIVED DETERMINED THIS EVENT WAS ALSO REPORTED UNDER MFR. REP. #3004209178-2012-05333. ALL FUTURE FOLLOW
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS STILL PARALYZED FROM THE WAIST DOWN. THE PATIENT HAS
EXPERIENCING PARALYSIS IN HER LEGS AND LOSS OF CONTROL OF HER BLADDER. THE PHYSICIAN EXPLANTED THE PADDLE LEA
MASS/HEMATOMA AND BELIEVES IT WAS PROCEDURE RELATED. THE PATIENT HAS REGAINED SOME LEG MOBILITY AND HAS B
WAS SUCCESSFULLY IMPLANTED AND PROGRAMMED WITH A PERMANENT SCS SYSTEM. TWO DAYS FOLLOWING THE PROCED
THE SCS SYSTEM IMPLANT DUE TO POSSIBLE CORD COMPRESSION AND CARDIOVASCULAR HYPO-PERFUSION. FOLLOW-UP IDE
PT SUFFERED PARALYSIS OF HIS LEGS DUE TO A HEMATOMA. THE PHYSICIAN BELIEVES THE HEMATOMA DEVELOPED DUE TO T
SURGEON DID NOT EXPLANT ANY COMPONENTS OF THE SCS SYSTEM. THE PT IS BEING TREATED TO RESOLVE THE SYMPTOMS
PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYP LEAD. (B)(4). THE ACTU
SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVEN
LAMINOTOMY FOR PADDLE ELECTRODE PLACEMENT IN SPINAL CORD STIMULATION: TECHNICAL REPORT AND CLINICAL RESUL
SURGICAL APPROACH FOR IMPLANTATION OF PADDLE ELECTRODES FOR SCS UNDER SPINAL ANESTHESIA OBTAINING THE BEST
INTRAOPERATIVE MONITORING AND CLINICAL RESULTS. SIXTEEN PATIENTS, AFFECTED BY NEUROPATHIC PAIN UNDERWENT TH
INTRODUCED AFTER FLAVECTOMY AND EACH PATIENT CONFIRMED THE CORRECT DISTRIBUTION OF PARESTHESIAS INDUCED B
PREOPERATIVE VALUES. NO PATIENTS REPORTED DISCOMFORT DURING THE PROCEDURE. IN ALL CASES, PARESTHESIAS COVER
MONTHS), 87.5% OF THE IMPLANTED PATIENTS HAD A GOOD RATE OF SATISFACTION WITH A MEAN VAS SCORE IMPROVEMEN
DISCOMFORT FOR PATIENTS OR NEUROSURGEONS. THE BEST INTRAOPERATIVE POSITIONING ALLOWS A BETTER POSTOPERATI
PATIENT 7, A (B)(6) FEMALE, DEVELOPED A SEVERE RIGHT LEG PARESIS CAUSED BY AN EPIDURAL HEMATOMA THAT REQUIRED
IN PLACE.
(B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED THE REVISION WAS BECAUSE THE LEAD WAS WRAPPED AROUND THE
MODEL#: 37712, SERIAL#: (B)(4), FOUND NO SIGNIFICANT ANOMALY. THE BATTERY HAD A REDUCED CAPACITY DUE TO OVERD
TOTAL RECHARGE COUNT IS 54. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS ON
TO THE LOCK MODE ON (B)(6) 2000. THE BATTERY WAS RECHARGED USING THE PHYSICIAN MODE RECHARGE (PMR) IN THE AN
THE TRACE REPORT. CHARGING RESUMED FOR 3 HOURS AND 38 MINUTES AND THE BATTERY CHARGED FROM 3.825V TO 4.04
OVERDISCHARGED STATE AND THAT THE PATIENT FELT STIMULATION IN THE WRONG LOCATION DESPITE R E-PROGRAMMING M
THAT INDICATED THAT REVISION SURGERY TOOK PLACE ON (B)(6), 2012 DUE TO THE OVERDISCHARGE OF THE DEVICE. DURING
SURGERY AND WOULD GO TO REHABILITATION AFTER RECOVERING. THE STIMULATION WAS IN RIGHT LOCATION AND THE PAT
2008-(B)(6) EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3708120 LOT# SERIAL# (B)(4) IMPLANTED: 2008-(B)(6) EXPLANTED:
LOT# SERIAL# (B)(4) IMPLANTED: 2008-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 37081 LOT# SERIAL# (B)(4) I
FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
(B)(4). IT WAS REPORTED THAT THE PATIENT HAD AN X-TREL SYSTEM WITH A LEAD IMPLANTED ON C2. THE PATIENT DEVELOPE
AFFECTED THE TUMOR. THE TUMOR WAS REMOVED. IT WAS REPORTED THAT IT LOOKED LIKE PARALYSIS HAD OCCURRED, HO
EXPLANTED ONLY ONE MONTH AFTER IMPLANT, FOR AN UNKNOWN REASON. SEVENTEEN YEARS AFTER THE IMPLANT/EXPLAN
HAD BEEN 17 YEARS AGO. THE PATIENT HAS BEEN SUCCESSFULLY REHABILITATED. (B)(4): LEAD MODEL 3487A, LOT# UNKNOWN
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A RETURN OF ACUTE PAIN. THE PAIN
PREVIOUS 6 MONTHS (SINCE APPROXIMATELY (B)(6) 2011). THE PATIENT MET WITH THE MANUFACTURING REPRESENTATIVE A
PHYSICIAN PROGRAMMER. THE PATIENT REPORTED MANY FALLS IN THE PAST BUT THE DATES WERE UNKNOWN AND THOUGH
LEFT LEG AND WAS USING CRUTCHES AND A WHEELCHAIR. THE PATIENT HAD ORTHOSCOPIC SURGERY ON HER LEFT KNEE AND
HAD A MENISCUS TEAR THAT OCCURRED IN (B)(6) 2009. THE 2ND LEAD WAS IMPLANTED TO PROVIDE MORE COVERAGE BECA
INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION SINCE LAST REPROG
THE PREVIOUS INS WAS LOCATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DA
PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37083
LEAD. (B)(4).
(B)(4). THE ATTORNEY ALLEGED ON (B)(6) 2013 THAT WITHIN TWELVE HOURS OF THE SURGERY THE PATIENT LOST BOWEL AND
DIFFICULTY PLACING AND CORRECTLY POSITIONING THE PADDLES. THE HCP REPORTEDLY STATED THAT THE PADDLES �JOGGE
AGAINST RESISTANCE CAUSING VISIBLE DEVIATIONS UPON THE SPINAL CORD.� THE HCP PULLED BACK ON THE LEADS � OF
AND RECOGNIZED THAT SHE HAD NO FEELING FROM HER BELLY BUTTON DOWN AND THAT HER RIGHT LEG WAS JERKING UND
TRANSFER THE PATIENT TO THE TOILET AND SHE TRIED TO STAND ON HER OWN BUT COULD NOT SUPPORT HER WEIGHT AND
PROBLEM AND THERE WAS NO EVIDENCE OF HEMATOMA. � THE SYSTEM WAS REMOVED LATER THAT DAY AND THE HCP CON
THAT THE �CORD APPEARED TO BE MILDLY COMPRESSED IN THE AREA OF THE SIGNAL VOID. THIS AREA EXTENDED FROM TH
LIVING, WAS INCONTINENT, AND HER PAIN WAS WORSE THAN IT WAS PRIOR TO THE ATTEMPTED IMPLANT. ABOUT NINE MON
THE HCP ACKNOWLEDGED THAT �HE MUST HAVE PRESSED TOO HARD ON THE PATIENT �S SPINAL CORD DURING IMPLANT.�
EXTREMITIES AND THE STIMULATOR WAS REMOVED. IT WAS NOTED THE PATIENT EXPERIENCED PARALYSIS AS A RESULT OF TH
LOSS OF QUALITY OF LIFE, PAST AND FUTURE MEDICAL EXPENSES, PAST AND FUTURE WAGE LOSS AND LOSS OF EARNING CAPA
THE PADDLE LEAD, THE PATIENT COULD NOT FEEL HER LEGS. THE LEAD WAS REMOVED, BUT THE PATIENT STILL SUFFERED FRO
REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. . PRODUCT ID 39565-6
PRODUCT TYPE: RECHARGER, PRODUCT ID 37744, LOT#, SERIAL# (B)(4), IMPLANTED, EXPLANTED, PRODUCT TYPE: PROGRAMM
DEVICE 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2012-05757. THE PT HAD TWO LEADS (FROM DIFFERENT LOTS). THE PT U
TO THE EMERGENCY ROOM. WHILE IN THE HOSPITAL, BOTH LEADS WERE REMOVED. THE PT ALSO UNDERWENT A LUMBAR DE
AND MOVEMENT. ALLEGEDLY, THE DOCTOR FEELS THE PT'S SYMPTOMS ARE PERMANENT AND ONGOING. THE PT WAS ADMIT
IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE
DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2012-05758. THE PT HAD TWO LEADS (FROM DIFFERENT LOTS). THE PT U
TO THE EMERGENCY ROOM. WHILE IN THE HOSPITAL, BOTH LEADS WERE REMOVED. THE PT ALSO UNDERWENT A LUMBAR DE
AND MOVEMENT. ALLEGEDLY, THE DOCTOR FEELS THE PT'S SYMPTOMS ARE PERMANENT AND ONGOING. THE PT WAS ADMIT
IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A SHOCKING SENSATION THREE TIMES IN THE PAST THREE WEEKS, D
PATIENT OWNED AN ELECTRIC WHEELCHAIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS
SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA; EXTENSION MODEL 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 200
IT WAS REPORTED THAT WHEN THE LEAD WAS PUT IN ON 2011-(B)(6), THE PATIENT'S LEGS WERE PARALYZED. THE PATIENT'S R
WORK EVEN THOUGH THE LEAD WAS REMOVED AND HE HAS NOT CHARGED THE DEVICE. THE PATIENT WAS RECOMMENDED
(B)(4). PRODUCT ID 39565-65 LOT# (B)(4) IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 37752 LOT# (
(4). IT WAS FURTHER REPORTED, THE PATIENT WAS INITIALLY IMPLANTED ON 2011 (B)(6) AND THE VERY NEXT DAY, THE LEADS
PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED:, PRODUCT TYP: LEAD. PRODUCT ID (B)(4), LOT#
TYP: PROGRAMMER, PATIENT. (B)(4). IT WAS REPORTED THAT STIMULATION WAS TURNING OFF. WHILE PATIENT WAS WALKING
PROGRAMMER, IT STATED STIM WAS OFF. THE PATIENT WAS USING HIS PROGRAMMER WITHOUT THE ANTENNA. THEY WERE
WAS NOTED. THE PATIENT USED STIMULATION AS AN ASSIST TO WALKING BECAUSE HE IS A PARTIAL PARAPLEGIC. STIM ALLOW
SYMPTOMS WAS NOTED AS LEFT LEG, RIGHT LEG AND BELOW THE WAIST. IT WAS CHALLENGING TO PROGRAM THE PATIENT G
THE MANUFACTURER'S REPRESENTATIVE HAD SPOKEN WITH THE PATIENT AND STIM WAS BACK ON AND WORKING. IF ADDITI
MEASURED AND FOUND TO BE WNL, NO X-RAYS PERFORMED. IT WAS FOUND THAT THE PATIENT'S ADAPTIVESTIM SITTING VO
CONTROL OVER WALKING VOLTAGES SINCE HE IS A PARTIAL PARAPLEGIC AND HIS WALKING MOTIONS ARE FELT TO BE SHORTE
MALFUNCTION WERE SEEN, IT WAS NOTED NONE OTHER THAN A POSSIBLE SUB-THRESHOLD MOBILE SETTING. WHEN THEY T
INTERVENTIONS WERE TAKEN OR PLANNED. AS OF THIS REPORTING, THE PATIENT HAD HAD EFFECTIVE THERAPY RESTORED. .
IT WAS REPORTED THAT THE PATIENT HAD BEEN IN A WHEELCHAIR FOR TWO YEARS. SHE HAD A GOOD RESPONSE DURING A S
AGAIN. IN RECOVERY AFTER THE FULL IMPLANT, THE PATIENT TOLD THE MD THAT SHE WAS NOT GETTING STIMULATION IN TH
FOR BETTER COVERAGE. SINCE THEN THE PATIENT WOULD ONLY EXPERIENCE RELIEF FOR A COUPLE OF DAYS AFTER PROGRAM
SUCCESSFULLY, AND THE PATIENT HAD BEEN REPROGRAMMED APPROXIMATELY SIX TIMES SINCE IMPLANT. ADDITIONAL INFOR
2011 (B)(6), EXPLANTED: UNKNOWN. PROGRAMMER: MODEL 37743, SERIAL# (B)(4). RECHARGER: MODEL 37752, SERIAL# (B)(
SUPPLEMENTAL SUBMITTED FOR ADDITIONAL INFORMATION RECEIVED AND FOR UPDATED CONCLUSION, DEVICE AND PATIEN
BUZZING SENSATION AFTER DEVICE WAS TURNED OFF WHEN LAYING DOWN. THE PATIENT DIDN'T NOTICE THIS WHILE UP AND
DUE TO LOOSE ELECTRICAL GROUNDING WIRE IN HER HOME. THE GROUNDING WIRE WAS REPAIRED. THE PATIENT WAS FEELI
NEW PHYSICIAN SINCE SHE HAD MOVED. IN LATER REPORTING, IT WAS NOTED THAT THE PATIENT WAS DISSATISFIED WITH TH
RUSHED AT THE APPOINTMENT AND DID NOT GET TO REVIEW ALL OF HER CONCERNS WITH THE PHYSICIAN. THE PATIENT WA
IN HER ABDOMEN/WAIST AREA. THE PATIENT COULD FEEL THE INS AND EXT/LEAD POKING OUT WHEN SHE LAY ON HER RIGHT
AROUND WHICH WAS CAUSING IRRITATION, INFLAMMATION AND THE AREA AROUND THE INS TO BE SWOLLEN. THE PATIENT
THE INS HAD SHIFTED PUTTING PRESSURE ON HER BLADDER WHICH WAS CAUSING THE INCONTINENCE. THE PATIENT HAD AN
INFORMATION REPORTED WHEN THE STIMULATION WAS ON THE PATIENT FELT A BURNING SENSATION. AS A RESULT THE PATI
HEALTH CARE PROVIDER (HCP) AS THEY HAD NOT SEEN THE PATIENT. THE PATIENT REPORTED THEY FOUND A NEW HEALTH CA
CONSUMER REPORTED THE PATIENT WAS GOING TO HAVE SOME WORK DONE WITH HER IMPLANTABLE NEUROSTIMULATOR (
HAVING PROBLEMS FINDING A HEALTHCARE PROVIDER (HCP) TO WORK WITH BECAUSE "THEY DON'T WORK WITH INSS IN THE
PRESSURE ON HER BLADDER, AND THE INS SITE WAS BURNING, SWOLLEN, AND RAW. THE PATIENT SPOKE WITH A MANUFACT
AN APPOINTMENT ON (B)(6) 2016. A REP LATER REPORTED THE PATIENT HAD SHOCKING AND HAD TRIGGER POINT THERAPY A
TRIGGER POINT THERAPY LIKE SHE HAD BEFORE. THE PATIENT NOTED THE HCP DID IT BEHIND HER BACK. THE PATIENT STATED
"EXCRUCIATING PAIN" AND IT WENT "DEEP TOWARDS THE NAVAL." THE PATIENT THOUGHT THE TRIGGER POINT DAMAGED TH
DOWN NEAR HER BLADDER DUE TO HER SCOLIOSIS. THE PATIENT'S SCOLIOSIS WAS CONFIRMED NOT TO BE RELATED TO HER D
DEPLETION. THE PATIENT MET WITH A SURGEON ON (B)(6) 2016. ADDITIONAL INFORMATION RECEIVED FROM A HCP REPORT
ABDOMEN AND THERE WAS EVIDENCE OF FLIPPING ON AN X-RAY OF THE ABDOMEN. THE PATIENT WAS INTERESTED IN A CHA
WILL BE SENT. RECHARGER MODEL # 37752, LOT # NKA022991N; PROGRAMMER MODEL # 37742, LOT # NJD031322N; EXTENS
IMPLANTED (B)(6) 2007, EXPLANTED UNKNOWN; LEAD MODEL # 3998, LOT # V012123, IMPLANTED (B)(6) 2007, EXPLANTED U
WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT WITH TH
RECEIVED REPORTED FROM THE HEALTH CARE PROVIDER (HCP) THAT THE PATIENT HAD NO INFECTION AND THAT THE PATIENT
WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. THE APPOINTMENT WAS SCHED
WERE HAVING PROBLEMS WITH IT FOR THE 4 YEARS PRIOR TO THE REPORT. THE DEVICE WAS NOT WORKING PROPERLY AND T
NOT FUNCTIONING. THE PATIENT'S DEVICE WOULD NOT HOLD A CHARGE AND HURT THEM. THE PATIENT NOTED THAT EVEN W
LAY ON THEIR RIGHT SIDE AND THE DOCTORS THOUGHT THAT THERE MAY BE AN INFECTION IN THE POCKET SITE. THE PATIENT
OF MONTHS PRIOR TO THE REPORT. THE PATIENT HAD WORKED WITH A MANUFACTURER REPRESENTATIVE IN THE PAST AND
(B)(4). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT USED THE DEVICE INITIALLY BUT SHE DIDN'T HAVE
BREAKDOWN" AND THREE TIMES A WEEK NURSES VISITED HER. IT WAS STATED THAT BY THE TIME THE PATIENT "GETS UP WA
HEALTH CARE PROVIDER TO CHARGE THE DEVICE FOR 30 MINUTES EACH DAY BUT IT "TAKES SO MUCH TIME JUST TO GET ONE
PREVIOUS TWO DAYS. THE PATIENT REPORTED THAT HER LEG PAIN WAS NOW WORSE THAN BEFORE SHE HAS THE DEVICE IMP
ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. . ADDITIONAL INFORM
OF HER TOES WHICH HAD BEEN OCCURRING "FOR DAYS". THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNE
NOTED THAT SHE RECEIVED A "POOR COMMUNICATION" SCREEN ON HER PATIENT PROGRAMMER TWO TIMES. COMMUNICAT
IT WAS NOTED THAT THE PATIENT IS A PARAPLEGIC AND IS IN A WHEELCHAIR. ON (B)(6) 2012, THE PATIENT REPORTED FEELING
INDICATED THE INS WAS ON. THE PATIENT TURNED THE STIMULATION OFF AND STATED SHE BELIEVED A "WIRE WAS HITTING
THOUGH SHE BELIEVED IT SHOULD BE. IT WAS ALSO NOTED THAT THE PATIENT HAD A FOLEY CATHETER AND EXPERIENCED "SK
PATIENT STILL FELT THE STIMULATION EVEN THOUGH THE DEVICE WAS OFF. SHE ALSO NOTED THAT IT WAS TAKING TOO LONG
HOURS. SHE ALSO STATED THAT SHE USED HER STIMULATION FOR LESS THAN 2 HOURS A WEEK. IF ADDITIONAL INFORMATION
3778-75, LOT#: V907489008, IMPLANTED: (B)(6) 2012, EXPLANTED: NA. ANCHOR MODEL: 3550-39, LOT#: N316092, IMPLANTE
ADDITIONAL INFORMATION RECEIVED FROM THE ATTORNEY ALLEGED THAT THE PHYSICIAN USED A SUTURE RETRIEVAL SNARE
THE LEAD, RESULTED IN THE INJURY TO THE DURA AND DIRECT TRAUMA TO THE SPINAL CORD. IT WAS ALSO REPORTED THAT
PATIENT HAD PERMANENT PARALYSIS FROM THE LEVEL OF THE INJURY (NEAR THE NAVAL) DISTAL DOWN TO THEIR TOES. IF AD
ADVANCING THE PATIENT'S LEAD, INTRA-OP. THE PHYSICIAN USED A SUTURE SNARE FOLLOWED BY A GREENBURG RETRACTOR
THE PATIENT WAS FOUND TO BE PARALYZED FROM THE WAIST DOWN. THE DOCTOR TOOK THE PATIENT BACK TO THE OPERAT
THROUGH THE PATIENT'S DURA. IT WAS BELIEVED THAT THE TIP OF THE SUTURE SNARE WENT THROUGH THE DURA AND POS
DURING AN ATTEMPTED MRI SCAN "THE LEAD WAS CLIPPED AND CONNECTED TO THE INS. THE CLIPPED WAS NEAR THE INS A
ENOUGH FOR THE MRI TO BE PERFORMED SUCCESSFULLY. THE PHYSICIAN WANTED TO PERFORM A SPINE MRI AND THE PATIE
CHANGES TO PATIENT'S CONDITION. . LEAD MODEL 39286-65 SERIAL# (B)(4) IMPLANTED: (B)(6) 2012 EXPLANTED: (B)(6) 2012;
THE PATIENT HAD CSF LEAK REPAIR IN MARCH. THE PHYSICIAN STATED THAT PUTTING THE LEAD IN SEEMED TO GO OKAY AND
AN MRI. THE MRI SHOWED SWELLING AROUND THE SPINAL CORD. THE PHYSICIAN MONITORED THE PATIENT FOR ROUGHLY 2
THAT TIME. THE PHYSICIAN ADDED THAT HE HAD WORKED WITH THE PATIENT FOR ROUGHLY 4 YEARS AND TRIED SEVERAL BA
HAD NOT BEEN INFORMED DIFFERENTLY.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOES NOT FEEL THAT THE PARALYSIS WAS PROCEDURE RELA
THE HEMATOMA, AND WHETHER THE HEMATOMA OCCURRED DURING THE IMPLANT PROCEDURE. THE PATIENT DID RECEIVE
PATIENT WASN'T ABLE TO MOVE THEIR LEGS DUE TO PARALYSIS. THE PATIENT IS UNABLE TO FEEL HER LEFT LEG AND HAS PART
REHABILITATING CENTER AND IS REGAINING THE USE OF HER LEGS.
IT WAS REPORTED THERE WAS A SHOCKING AND JOLTING SENSATION WHEN THE PATIENT TRIED TO RUB HER NECK. THE STIM
CURRENTLY OFF BUT THEN LATER STATED "CERTAIN PARTS" OF THE DEVICE WERE ON, SO IT WAS UNCLEAR WHETHER THE DEV
HEALTH CARE PROFESSIONAL THE PAIN WAS DUE TO THE "WIRES" IN HER NECK. REPROGRAMMING HAD BEEN ATTEMPTED BU
DUE TO SURGICAL RISK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITION
'SEVERE' LACK OF MEMORY RETENTION ISSUES AND IT WAS DIFFICULT FOR THE PATIENT TO REMEMBER WHAT WAS GOING O
ISSUE, BUT IT WAS NOT RELATED TO THE DEVICE. AT THE PATIENT'S MOST RECENT APPOINTMENT, THE PATIENT STATED THE D
0.3 TO 0.7 VOLTS, AND THEN THE PATIENT WAS 'FINE'. IT WAS NOTED THE STIMULATION WAS HELPING THE PATIENT AND PRO
#V029694 IMPLANTED: (B)(6) 2010, LEAD MODEL 3888-45 LOT #V375109 IMPLANTED: (B)(6) 2010, LEAD MODEL 3986A LOT #N
(B)(6) 2010, EXTENSION MODEL 37082-40 SERIAL #(B)(4) IMPLANTED: (B)(6) 2010, ADAPTOR MODEL 3550-09 LOT #LC3722 IM
37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-45, LOT# V386351, IMPLANTED: (B)(6) 2010
IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT# N140442, IMPLANTED: (B)(6) 2010, PRODUCT TYPE
EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUC
PRODUCT TYPE RECHARGER; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-45, LOT# V0
ID 3888-45, LOT# V386351, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3550-09, LOT# LC3722, IMPLANTED: (
PRODUCT ID 3986A, LOT# N138329, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID NEU_SILICONEANCHOR, PRO
FLIGHT OF STAIRS CAUSING BOTH THE LEFT AND RIGHT LEADS TO MOVE. IT WAS FURTHER REPORTED THAT THE REVISION WA
HER SCAR TISSUES." IT WAS ALSO NOTED THAT THE PATIENT'S ANTENNA WILL STICK TO HER IMPLANT IN "A MAGNETIC FASHIO
INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT'S LEAD. IT WAS REPORTED THE PATI
EXPLANTED ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE DOCTOR HAD REM
THE HEALTHCARE PROVIDER (HCP) SAID IT WOULDN'T MAKE A DIFFERENCE. THE HCP HAD" CUT HER ALL THE HECK" AND SHE
HCP. SHE THEN DISCONNECTED THE CALL. RELEVANT MEDICAL HISTORY INCLUDED CERVICAL RADICULOPATHY. FURTHER FOLLO
REPORTED THE PATIENT USED TO HAVE A FULL BLOWN STIMULATOR IN HER, THE TOP PART WAS TAKEN OUT AND THERE WER
CALLED HER YESTERDAY AND WANTED TO AN MRI. IT WAS NOTED THE PATIENT HAD A PLATE AND SCREWS AND THERE WAS A
DOCTOR SAID THEY DID NOT. THE PATIENT REPORTED HER PRIMARY CARE PHYSICIAN AND HER PAIN CLINIC DOCTOR BELIEVED
COULD NOT EVEN SEE HER DISCS IN HER NECK WHICH IS WHY SHE WAS SENT TO INFECTIOUS DISEASE. THE PATIENT WENT TO
INFECTION WAS SERIOUS AND SHE WAS TOLD SHE COULD GO TO THE EMERGENCY ROOM. ADDITIONAL INFORMATION RECEIV
DISEASE WHO STATED SHE NEEDED A BONE BIOPSY AND RADIOLOGY WANTED AN MRI PERFORMED. IT WAS NOTED THE PATIE
IT WAS 'NOT WORKING AND WAS ON THE WRONG SIDE.' IT WAS REPORTED THE 'ELECTRODES MOVED' AND THE 'TOP' WAS TA
REMOVED OR ONLY THE LEAD. INFORMATION CONCERNING THE FRAGMENTS LEFT IN THE PATIENT �S NECK WAS PREVIOUSLY
WERE A CONTINUING PART OF THE NARRATIVE FOR THIS EVENT. THEREFORE ANY FUTURE INFORMATION CONCERNING THE F
PIECE CALLED AN ANCHOR, THAT WERE LEFT INSIDE HER AND SUBSEQUENTLY REMOVED, CAUSED HER NECK TO SWELL AND C
CONFIRMED THAT THE PATIENT HAD ITEMS LEFT IMPLANTED. IT WAS NOTED THAT THESE ITEMS WERE REMOVE TWO WEEKS
IT WAS REPORTED THAT THE PATIENT HAD NO PARASTHESIA (STIMULATION) FOLLOWING IMPLANTATION OF THE IMPLANTABL
(6) 2012, THE LEAD WAS REPLACED BY A HEMI-LAMINECTOMY PROCEDURE. ON (B)(6) 2012 (AT 1 AM), LEG PARALYSIS APPEAR
PROCEDURE FOR THE "LEFT WIDE" OF THE TWO VERTEBRAL BODIES AND FIXED WITH "BOLHEAL." THE PATIENT WAS REPORTE
NEU_UNKNOWN_LEAD LOT# UNK IMPLANTED: (B)(6) 2012 EXPLANTED: (B)(4) 2012; LEAD MODEL 39565-65 LOT# UNK SERIAL
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2218-50, (B)(4), DESCRIPTION: LIN
LEG. A CT SCAN TAKEN SHOWED THAT PATIENT'S EPIDURAL SPACE WAS TOO NARROW FOR THE LEADS CAUSING THE PARALYSI
LEAD MODEL 39565-65 (B)(4) IMPLANTED: 2012-(B)(6) EXPLANTED: 2012-(B)(6). FOLLOW-UP INFORMATION REPORTED INDICA
PATIENT WAS ABLE TO WEIGHT BEAR AND URINATE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPO
IMMEDIATELY TOOK THE PATIENT TO THE OPERATING ROOM AND REMOVED THE LEAD. THE NEUROSTIMULATOR WAS PLUGGE
MOTOR FUNCTION. THE PATIENT'S "T SPINE HAD A HERNIATION OF DISC AND MILD STENOSIS CAUSED CROWDING ISSUE." AD
MODEL NEU_UNKNOWN_LEAD SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK.
A REPORT WAS RECEIVED THAT A PATIENT HAD A HEMATOMA REMOVED FROM THEIR EPIDURAL SPACE. THE PATIENT'S SYMPT
REMAIN IN THE HOSPITAL UNTIL THEY GAIN STRENGTH BACK IN THEIR LEG. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONE
THE PT RECEIVED THE SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THE PT BECAME COMBATIVE IN POST-OPERATIVE RECOV
HEMATOMA. A ST JUDE MED REP WAS LATER NOTIFIED THAT THE ENTIRE SCS SYSTEM WAS REMOVED DUE TO THE PT NEEDIN
ASSISTANT REPORTED THE PT SUFFERED A CARDIOVASCULAR DEFICIT BELIEVED TO BE AN ACUTE MYOCARDIAL INFARCTION. T
BEEN ADMITTED TO A REHABILITATION FACILITY. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNAB
MEDICAL HISTORY.
A MONTH AFTER IMPLANTED DEVICE STOPPED WORKING, PT FEELS SEVERE PAIN, LEG AND HIP PARALYSIS. FEELS SHE'D RATHE
ABOUT A YEAR AND A HALF. NOW BUT SHE STILL GETS ELECTRICAL CURRENT FROM HER TOE ALL THE WAY UP TO HER HEAD A
THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THE PT HAD PARALYSIS SYMPTOMS ON (B)(6) 2011 AND W
SUBDURAL HEMATOMA WAS IDENTIFIED DURING THE PROCEDURE. IT WAS REPORTED THE PHYSICIAN DID NOT BELIEVE THE I
UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT
PROGRAMMER MODEL 37743, SERIAL # (B)(4); RECHARGER MODEL 37752, SERIAL # (B)(4). IT WAS REPORTED THAT A RECHAR
PARALYSIS AND A HEMATOMA AT THE SURGICAL SITE. PARALYSIS DID NOT OCCUR IMMEDIATELY AFTER THE SYSTEM WAS IMP
IMPLANTATION INDICATED "SATISFACTORY BATTERY CONNECTION." REMOVAL OF SYSTEM HAD NOT YET RESOLVED THE PARA
THE PATIENT'S SPINAL FLUID LEAK RESOLVED. THE PATIENT OUTCOME IS NOTED AS GOOD; HOWEVER, THE PATIENT CONTINUE
FURTHER CLARIFIED THAT THE PATIENT DEVELOPED A EPIDURAL HEMATOMA. A LAMINECTOMY TO T8-T12 WAS ALSO PERFOR
DRAINED. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT HAD BEEN TRANSFERRED TO A HOSPITAL FOR REHABILITA
DEVICE REPORT 2 OF 2: REFERENCE MFR REPORT: 1627487-2011-09440. THE PATIENT RECEIVED THE SCS SYSTEM ON (B)(6) 20
RIGHT SIDE. ADDITIONALLY, THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE HAD ALLOY PROBLEMS CAUSING TISSUE EROSIO
THE EXPLANTED PRODUCTS HAVE BEEN RETAINED BY THE FACILITY. METHOD: THE DEVICE HISTORY AND STERILIZATION RECOR
ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE
FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT
DEVICE REPORT 1 OF 2: REFERENCE MFR REPORT: 1627487-2011-09441. THE PATIENT RECEIVED THE SCS SYSTEM ON (B)(6) 20
RIGHT SIDE. ADDITIONALLY, THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE HAD ALLOY PROBLEMS CAUSING TISSUE EROSIO
THE EXPLANTED PRODUCTS HAVE BEEN RETAINED BY THE FACILITY. THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISOR
REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REP
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS FOLLOWING SURGERY FOR HIS FIRST SURGICAL LEAD. THE LEAD
ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. ADDITIONAL R
IMPAIRMENT WAS INCORRECTLY CHECKED ON THE INITIAL REPORT. LEAD: MODEL 3998, LOT# J0519359V, IMPLANTED: (B)(6) 2
EXPLANTED: NA, EXTENSION: MODEL 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: NA, NEUROSTIMULATOR
EXPLANTED: NA, LEAD: MODEL 3487A-33, LOT# J0527006V, IMPLANTED: (B)(6) 2005, EXPLANTED: NA.
METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULT - THE DEVICE HISTORY AND STERILIZA
COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED
SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. THE PT RECEIVED THE SCS SYSTEM ON (B)(6) 2011. I
HAD AN ONSET OF GRADUAL PARESIS DEVELOPING DUE TO AN EPIDURAL HEMATOMA. THE PT ALSO EXPERIENCED SEVERAL FA
BEEN RESOLVED. THE PHYSICIAN BELIEVES THE EVENT WAS DEVICE RELATED DUE TO THE SIZE AND THE STIFFNESS OF THE SYS
IT WAS REPORTED THAT IMPEDANCES ON THE LEAD WERE ABOVE 10,000 OHMS. THE PHYSICIAN AND NURSE DID NOT KNOW
AND IT WAS REPORTED THAT THE PATIENT WAS FINE. LEAD MODEL 3877-45 LOT# 0204997170 IMPLANTED: (B)(6) 2011 EXPLA
DEVICE ANALYSIS FOR THE STYLET REVEALED NO DEVICE PROBLEMS.
DEVICE 3 OF 3. REFERENCE MFR REPORT: 1627487-2011-04444, REFERENCE MFR REPORT: 1627487-2011-04445. THE PT RECE
SHOULD HAVE BOTH OF HIS SCS IPGS REMOVED. IT WAS REPORTED ONE OF THE IPG SITES APPEARED TO HAVE SOME EROSION
WANT TO HAVE A SURGICAL PROCEDURE TO REMOVE THE IPGS BECAUSE HE DOES NOT WANT TO END UP IN A WHEELCHAIR F
STATED HE WOULD CONTACT HIS PHYSICIAN. EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIE
NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY. THE DEVICE WAS, THEREFORE, APPROVED FOR USE. THE DHR
THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND
REGARDING MEDICAL HISTORY.
STATED HE WOULD CONTACT HIS PHYSICIAN. EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIE
THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE
OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARD
STATED HE WOULD CONTACT HIS PHYSICIAN. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. EVAL: METHOD:
FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF T
TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EV
ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN 2011 WITH ADVICE FROM THE PATIENT'S PAIN DOCTOR THE PATIEN
TOOK 3 PAIN PILLS INSTEAD OF THE 5+ DAILY. IT WAS NOTED THAT THE A SURGERY DATE FOR THE PERMANENT IMPLANT WAS
COMPLICATIONS AND SINCE EVERYTHING WAS OKAY THE PATIENT COULD GO HOME INSTEAD OF STAYING THE NIGHT IN THE H
SUDDEN BENDING. IT WAS NOTED THAT THE PATIENT TOOK NICE SLOW MOVEMENTS NOT KNOWING THAT ALL OF THAT TIME
STARTED FALLING TO THE FLOOR. IT WAS NOTED THAT THE PATIENT COULD NOT FEEL THEIR LEGS. IT WAS FURTHER NOTED TH
MOVED THE WRONG WAY AND NEEDED TO REST AND SHE WOULD BE OKAY. IT WAS NOTED THAT DID NOT WORK AND THE PA
EMERGENCY SURGERY. IT WAS NOTED THAT THE PATIENT'S NEXT MEMORY WAS (B)(6) AND SHE WAS BEING MOVED FROM TH
HAD A VERY ROCKY ROAD TO RECOVERY AND FROM (B)(6) 2011 - (B)(6) 2012 THE PATIENT ALMOST DIED 3 TIMES FROM DEVE
DID NOT HAVE ANY MEMORY DURING THAT TIME OTHER THAN THE DAY THE PATIENT WENT INTO REHAB. IT WAS NOTED THA
WAS NOTED THAT WHAT THE PATIENT HAD LEARNED IN "HEATHSOLUTIONS" DIRECTLY AFTER BECOMING A PARAPLEGIC WAS G
2 SURGERIES FOR A SUPRAPUBIC CATHETER, MORE THAN 23 UTI INFECTIONS, 2 BROKEN FEMURS, 1 BROKEN TIBULA, 1 BROKE
REHABS, AND NURSING FACILITIES MORE THAN SHE WAS IN HER OWN HOME. IT WAS NOTED THAT THE PATIENT HAD BEEN ON
HEMATOMA THE DAY AFTER IMPLANT. THE HEMATOMA RESULTED IN LOWER EXTREMITY PARALYSIS AND HOSPITALIZATION. IT
PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF
REPORTED THE PATIENT HAD MID-BACK PAIN AND SUDDEN ONSET OF PARALYSIS BELOW THE CHEST. IT WAS NOTED A CT OF T
THE THORACIC SPINE. IT WAS NOTED THE PATIENT THE PATIENT HAD SURGERY TO EVACUATE THE THORACIC HEMATOMA. IT W
PERMANENTLY PARAPLEGIC. IT WAS NOTED THE PATIENT HAD A HISTORY OF THE FORMATION OF BLOOD CLOTS AND HAD MU
EMBOLISMS. IT WAS NOTED THE PATIENT WAS ON ANTI-COAGULATION THERAPY AND A BLOOD THINNER MEDICATION. IT WA
AFTER IMPLANT AND WAS ABLE TO AMBULATE WITH NO NEUROLOGICAL DEFICIT. IT WAS NOTED THE PATIENT HAD UNDER GO
SKIN BREAKDOWNS, URINARY TRACT INFECTIONS, DEPRESSION, AND OTHER MEDICAL AND EMOTIONAL ISSUES ASSOCIATED W
WHEELCHAIR. IT WAS NOTED THE PATIENT HAD PAIN AND SUFFERING, MENTAL AND EMOTIONAL DISTRESS, DISFIGUREMENT
NEUROSTIMULATOR: MODEL 37702, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: UNKNOWN. LEAD: MODEL 377760,
UNKNOWN. EXTENSION: MODEL 7495-51, SERIAL# (B)(4), IMPLANTED: 2001 (B)(6), EXPLANTED: UNKNOWN. EXTENSION: MOD
EXPLANTED: UNKNOWN. PROGRAMMER: 37742, SERIAL# (B)(4). ACCESSORY: MODEL 37752, SERIAL# (B)(4). PROGRAMMER: 7
WAS REPORTED THAT THE PATIENT FELL OUT OF HER WHEELCHAIR AND HIT THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (
APPOINTMENT TO HAVE HER DEVICE INTERROGATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAI
IT WAS REPORTED THAT THE PATIENT FELL OUT OF HER WHEELCHAIR AND HIT THE IMPLANTABLE NEUROSTIMULATOR (INS) O
APPOINTMENT TO HAVE HER DEVICE INTERROGATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAI
2004-(B)(6), EXPLANTED: UNKNOWN, LEAD MODEL 377760, LOT# N0028101, IMPLANTED: 2005-(B)(6), EXPLANTED: UNKNOW
2001-(B)(6), EXPLANTED: UNKNOWN, EXTENSION MODEL 3708160, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), EXPLANTED: UNK
ACCESSORY MODEL 37752, SERIAL# (B)(4) PROGRAMMER 7435, SERIAL# (B)(4). ADDITIONAL INFORMATION SHOWED THE PAT
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-1110-02, (B)(4), DESCRIPTION: IP
FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF TH
RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED. A REPORT WAS RECEIVED THAT
PARALYSIS IS DEVICE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE, BUT WAS STILL EXP
THE PT RECEIVED THE SCS SYSTEM ON (B)(6) 2011. PT REPORTED PARALYSIS IN HER LEGS TO THE SURGEON THE FOLLOWING D
WAS DIAGNOSED WITH AN EPIDURAL HEMATOMA. NO DIAGNOSTIC IMAGING WAS CONDUCTED AFTER THE ONSET OF SYMPT
OPINION, THIS EVENT WAS NOT DEVICE RELATED. THE EXPLANTED SYSTEM HAS NOT BEEN RETURNED. F/U INDICATED THAT P
PHYSICAL THERAPY. EVAL, METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEV
DEVICE. CONCLUSION - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE D
IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO PARALYSIS IN HIS LEGS. ACCORDING TO THE PHYSICIAN THE PA
ORIGINALLY IMPLANTED FOR FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE
DEVICE RELATED BUT PROCEDURE RELATED. THE PATIENT WAS ORIGINALLY IMPLANTED FOR FAILED BACK SURGERY SYNDROM
DESCRIPTION:PRECISION IMPLANTABLE PULSE GENERATOR (IPG) MODEL#:SC-2218-50, SERIAL#: (B)(4) MODEL DESCRIPTION:LI
MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALY
FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
EVAL: COMPLAINT COULD NOT BE CONFIRMED THROUGH TESTING ALONE. THE RETURNED LEADS WERE RETURNED CUT AND
AND NO VISUAL ANOMALIES WERE OBSERVED. SJM HAS LIMITED INFO RELATED TO THE PT'S MED HISTORY AND IS UNABLE TO
HISTORY. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2011, INCLUDING TWO LEADS (WITH THE SAME LOT NUMBER). POST OP
NOT CHANGE. THE PT ALSO REPORTED PAIN IN BOTH KNEES. THE PHYSICIAN ORDERED A CT SCAN. BOTH EPIDURAL HEMATOM
SCS SYSTEM WAS EXPLANTED. THE PHYSICIAN ORDERED TWO MRIS, INCLUDING A HIGH DEFINITION MRI. THESE MRI RESULTS
(B)(4). IT WAS REPORTED THAT THE PT EXPERIENCED SWELLING IN THE BACK, PARTIAL PARALYSIS/NUMBNESS FROM THE NAVE
HAD "CONVERSION DISORDER". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE
(B)(4). IT WAS REPORTED THAT THE PT COULD NOT ADJUST STIMULATION, DESPITE TRYING MULTIPLE SETS OF NEW BATTERIES
AFTER PUTTING IN NEW BATTERIES AND THE PT WAS ABLE TO TURN ON STIMULATION. THE PROGRAMMER'S IMPLANTABLE N
A CLINICIAN PROGRAMMER ON (B)(6) 2011 AND THE PT WAS TOLD "EVERYTHING WAS WORKING FINE." IT WAS ALSO REPORT
REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
A REPORT WAS RECEIVED THAT THE PATIENT MAY BE EXPLANTED DUE TO PARTIAL PARALYSIS IN HIS LEGS. THE PHYSICIAN BEL
PATIENT WAS INITIALLY IMPLANTED. THE PHYSICIAN SUSPECTS SPINAL CORD COMPRESSION DUE TO LEAD PLACEMENT AND S
THE EVENT: MODEL#:SC-1110-02 (B)(4) MODEL DESCRIPTION:IPG KIT (WITHOUT PULL-THROUGH TUNNELER) ADDITIONAL INF
EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED B
(B)(4). IT WAS REPORTED THAT THERE WAS SOME DIFFICULTY GETTING THE LEAD NEXT TO THE SPINAL CORD PLACED DURING
IN THE FINGERS OF HER RIGHT HAND AND HER RIGHT LEG AND FOOT. SHE ALSO EXPERIENCED NUMBNESS IN HER ABDOMEN.
THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL). A LAMINECTOMY WAS SCHEDULED TO REPAIR THIS PROBLEM AND TOOK P
REMAINED AT THE HOSPITAL UNDER PAIN MANAGEMENT UNTIL (B)(6) 2011. THE PATIENT THEN WAS UNDERGOING PHYSICIA
WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT W
(6) 2011 TO REVISE THE LEAD LOCATION. FOLLOWING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PA
OBTAIN ADDITIONAL DETAILS REGARDING THE PATIENT'S CURRENT HEALTH STATUS HAVE BEEN UNSUCCESSFUL. SJM HAS LIMI
HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A REVISION DUE TO THE IPG BEING TILTED IN THE POCKET. AD
PUSH ON THE IPG. THE IPG WAS REPOSITIONED IN THE POCKET AND THE PATIENT WAS REPORTEDLY DOING FINE.
BILATERAL LOWER EXTREMITY PARALYSIS FOLLOWING PLACEMENT OF SPINAL CORD STIMULATOR (ALSO HAD EPIDURAL HEM
MORPHINE, ROLLED TO SIDE - SHORTLY AFTER THAT BEGAN TO NOTICE WORSENING NUMBNESS FOLLOWED BY MOTOR WEAK
THAT THE SPINAL CORD STIMULATOR OR ANCHORS HAD SHIFTED. NO EVIDENCE OF DIRECT SPINAL CORD TRAUMA. HEMATOM
MATURE HEMATOMA. A REVISION LAMINECTOMY WAS PERFORMED. STIMULATOR WAS REMOVED. ADMITTED TO HOSPITAL F
(B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED W
WWW.PAINPHYSICIANJOURNAL.COM. LITERATURE: SMITH, CLARK, LIN JOHN, SHOKAT MAX, DOSANJH SONNY, AND CASTHELY
SUMMARY: THIS ARTICLE DISCUSSES IN DETAIL OF FOUR OCCURRENCES OF NEUROLOGICAL COMPLICATION AFTER SPINAL CO
CASES INVOLVED INJURY SECONDARY TO EPIDURAL HEMATOMA, CORD CONTUSION OR THORACIC DISC HERNIATION. EVENT 4
LUMBAR FUSION SURGERIES AND WHO ALSO HAD MILD MID-THORACIC PAIN, EXPERIENCED A WORSENING NUMBNESS AND
EXTREMITY THREE DAYS AFTER SCS IMPLANTATION. THE STIMULATOR WAS REMOVED AND AN MRI SHOWED A LARGE THORA
SCAN SHOWED: AT T6-7 THERE WAS A LARGE PARTIALLY CALCIFIED ANTERIOR SOFT TISSUE DENSITY SUSPICIOUS FOR A LARGE
T8-9 THERE WERE CALCIFICATIONS IN THE ANTERIOR CANAL CONTRIBUTING TO SEVERE CENTRAL CANAL STENOSIS. THE PT UN
AND DECOMPRESSIVE LAMINECTOMY FROM AT T7-9 WITH POSTERIOR INSTRUMENTATION AND FUSION FROM T6 THROUGH
OCCUPATIONAL THERAPY. THE PT WAS AT A MAXIMAL ASSIST LEVEL FOR BED TO CHAIR TRANSFERS. TWELVE DAYS AFTER SURG
KNEE EXTENSORS AND ANKLE DORSIFLEXORS AND 4/5 STRENGTH IN THE LONG TOE EXTENSORS AND ANKLE PLANTAR FLEXOR
PROGRESSED TO 1/5 STRENGTH. AFTER THE 33-DAY STAY, THE PT REQUIRED A WHEELCHAIR AND ROLLING WALKER AND MAX
PLANTAR FLEXORS AND LONG TOE EXTENSORS HAD 4/5 STRENGTH, THE LEFT HIP FLEXORS HAD 2/5 STRENGTH AND THE KNEE
LITERATURE: SMITH, CLARK, LIN JOHN, SHOKAT MAX, DOSANJH SONNY, AND CASTHELY DIONNE. "A REPORT OF PARAPARESIS F
IN DETAIL FOUR OCCURRENCES OF NEUROLOGICAL COMPLICATION AFTER SPINAL CORD STIMULATOR (SCS) IMPLANTATION. A
EPIDURAL HEMATOMA, CORD CONTUSION OR THORACIC DISC HERNIATION. EVENT: A (B)(6) MALE PT WITH A 10-YEAR HISTOR
AFTER INITIAL IMPLANT OF THE SCS SYSTEM AN ACUTE DEVELOPMENT OF MID-BACK PAIN AND RAPID PROGRESSIVE WEAKNE
PT WAS TAKEN TO THE EMERGENCY DEPT AND GIVEN INTRAVENOUS METHYLPREDNISOLONE. CT SCANS SHOWED AN EPIDUR
UNDERWENT A THORACIC T8-0 LAMINECTOMY WITH EXCISION OF THE HEMATOMA AND REMOVAL OF THE SCS LEADS WITH N
THE PT WAS TRANSFERRED TO ACUTE INPATIENT REHABILITATION. MOTOR STRENGTH TESTING REVEALED 0/5 STRENGTH IN B
WAS AT SUPERVISION LEVEL FOR WHEELCHAIR TRANSFERS, ACTIVITIES OF DAILY LIVING, BLADDER AND BOWEL PROGRAM. SE
SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. ADDIT
LITERATURE: SMITH, CLARK, LIN JOHN, SHOKAT MAX, DOSANJH SONNY, AND CASTHELY DIONNE. "A REPORT OF PARAPARESIS F
IN DETAIL FOUR OCCURRENCES OF NEUROLOGICAL COMPLICATION AFTER SPINAL CORD STIMULATOR (SCS) IMPLANTATION. A
EPIDURAL HEMATOMA, CORD CONTUSION OR THORACIC DISC HERNIATION. EVENT: A (B)(6) FEMALE PT WITH A HISTORY OF C
L3, L4 AND L5 LEVELS, EXPERIENCED SUDDEN LOW BACK PAIN WITH BILATERAL LOWER EXTREMITY DYSTHESIAS FOLLOWED BY
LEADS WERE REMOVED, AND AN MRI REVEALED MODERATE THE SEVERE CANAL STENOSIS AT L1/L2 AND L2/L3 WITH EPIDURA
DECOMPRESSIVE THORACIC AND LUMBAR LAMINECTOMIES OF T11 THROUGH L2 WERE PERFORMED. THE PT WAS TRANSFERR
GREATER THAN RIGHT) AND DECREASED SENSATION, AND NEUROGENIC BOWEL AND BLADDER. MANUAL MUSCLE TESTING RE
STRENGTH, AND 2/5 KNEE EXTENSION AND ANKLE DORSIFLEXION STRENGTH. DEEP TENDON REFLEXES WERE 2/4 AT THE BILA
DISCHARGE, THE PT HAD RECOVERED FULL MOTOR STRENGTH IN BOTH LEGS AND WAS CONSIDERED MODIFIED INDEPENDEN
COPY OF THE LITERATURE ARTICLE. (B)(4): NEUROGENIC BOWEL AND BLADDER. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC
COPY OF THE ARTICLE IS AVAILABLE AT WWW.PAINPHYSICIANJOURNAL.COM.
THE PT RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT DEVELOPED A
LEAD. F/U ON THIS MATTER FOUND THAT THE PT STILL SUFFERS FROM PARALYSIS IN BOTH LOWER EXTREMITIES. SHE HAS BEE
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY
(B)(4). IT WAS REPORTED THAT THE PT'S DEVICE WAS EXPLANTED IN (B)(6) 2010, SUBSEQUENT TO THE PT EXPERIENCING PARA
AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
(B)(4). LITERATURE: KLOSS B, SULLIVAN A, RODRIGUEZ E. EPIDURAL HEMATOMA FOLLOWING SPINAL CORD STIMULATOR IMPL
EPIDURAL HEMATOMA THAT FORMED AFTER PLACEMENT OF AN EPIDURAL SPINAL CORD ELECTRODE. THE PT WAS A (B)(6) M
WEAKNESS IN BOTH LEGS. THESE SYMPTOMS WERE PRECEDED BY A SUDDEN ONSET OF PARALYSIS BELOW THE WAISTLINE WI
PHYSICAL EXAM SHOWED STABLE VITAL SIGNS, TENDERNESS TO PALPATION IN THE SPINE, DECREASED SENSATION T12 AND BE
RESONANCE IMAGES OF THE THORACIC AND LUMBAR SPINES WERE OBTAINED, REVEALING AN EPIDURAL HEMATOMA FROM
EPIDURAL FAT AND CSF REVEALED THE HEMATOMA WAS IN THE EPIDURAL SPACE DISPLACING THE DURA ANTERIORITY. THE PT
PROCEDURE WELL AND WAS DISCHARGED 6 DAYS LATER TO A REHABILITATION FACILITY WITH SOME IMPROVEMENT OF HIS LO
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG IMPLANT SURGERY WAS CANCELLED DUE TO COMPLICATIONS CAUSED BY T
CANCELLED THE SURGERY AND ADVISED THE PATIENT THAT HE WAS NOT A SURGICAL CANDIDATE AT THIS TIME. THE PATIENT
PRODUCTS WERE EVEN OPENED AND/OR USED AT THAT TIME. DEVICE EXPIRATION DATE: N/A.
THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT THE PHYSICIA
POSTOPERATIVE, AND SHE DEVELOPED PARALYSIS FROM THE CHEST DOWN. THE PHYSICIAN EXPLANTED THE SYSTEM ON (B)(6
HEMATOMA, AND HE REPORTED THAT THE PATIENT'S SYMPTOMS RESOLVED POSTOPERATIVE. SJM HAS LIMITED INFORMATION
REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
THE PATIENT ((B)(6)) RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2011 FOR RIGHT LEAD SCI
PROCEDURE. IT WAS REPORTED THAT A DURAL SEPARATOR HAD BEEN USED IN THE PROCEDURE. THE PHYSICIAN ALLEGEDLY D
RIGHT LEG, AND SHE WAS TAKEN BACK INTO SURGERY. THE PHYSICIAN STATED THAT THE PARALYSIS WAS TEMPORARY, AND FO
STATED THAT THE PATIENT SHOULD WAIT TO BE PROGRAMMED IN APPROXIMATELY SIX WEEKS. NO FURTHER INFORMATION IS
A REPORT WAS REC'D THAT THE PT'S STIMULATION CAUSED THE WHEELCHAIR BOUND PT TO STRAIGHTEN OUT HER KNEE. TH
THE ISSUE WAS NOT RESOLVED. THE PT MET WITHOUT AN ORTHOPEDIC SURGEON WHO DETERMINED THAT THE PT'S FEMUR
REPROGRAMMED WITH LOWER SETTINGS BY THE BSN SALES REP AND IS RECEIVING ADEQUATE STIMULATION.
(B)(4). IT WAS REPORTED THAT THE PT CLAIMED THAT THE CURRENT OR AMPLITUDE ON THE IMPLANTABLE NEUROSTIMULATO
INTERMITTENTLY EVERY DAY. THE PHYSICIAN WAS WITH THE PT FOR 30 MINUTES AND DIDN'T SEE THE INCREASE OF THE INS.
"INCREASE" FELT LIKE A HIGH VOLTAGE/CURRENT IN THE AREA, BUT THE PT COULDN'T SEE IT ON THE DISPLAY OF THE PT PROG
DIARY WAS OBTAINED FROM THE PT WHERE THE PT GRADED THE EVENTS. THE IMPEDANCES WERE NORMAL. IT WAS NOTED T
CHRISTMAS. THE PT EXPERIENCED 27-29 PAINFUL SHOCKS. REVIEW OF INTERROGATION FROM (B)(6) 2011 NOTED THAT FROM
PROGRAM AND ONE AMPLITUDE. SO, THE CHANGE IN STIMULATION SENSATION DID NOT SEEM TO BE INITIATED BY CHANGES
MANAGE TWO PROGRAMS. THE PT HAD A SHOCK WHILE AT THE PHYSICIAN'S OFFICE SITTING IN HIS WHEELCHAIR ON (B)(6) 2
FELT LIKE AN ELECTRIC SHOCK. FURTHER TROUBLESHOOTING WAS STILL BEING CONSIDERED. NO PT OUTCOME WAS REPORTE
IT WAS REPORTED THAT THE PT WAS IMPLANTED ON (B)(6) 2010. THE PT THEN EXPERIENCED A FALL; THE DETAILS OF THE FAL
AMBULANCE TO THE EMERGENCY ROOM IN THE MIDDLE OF THE NIGHT. THE PT COMPLAINED OF LEG WEAKNESS AND SEVERE
LOSS OF LOWER EXTREMITY MOVEMENT. IT WAS UNCLEAR WHEN THE PARALYSIS ACTUALLY OCCURRED. IT WAS NOTED THAT
SYSTEM WAS REMOVED (B)(6) 2010, DUE TO AN EPIDURAL HEMATOMA AT T7 AND T9-10 AREA WHERE THE LEAD WAS. AFTER
RIGHT SIDE. ADD'L INFO REPORTED THAT PT RECOVERED W/O SEQUELA. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT TH
DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2010-04266. THE PT REC'D HER SCS SYSTEM ON (B)(6) 2010 CONSISTING O
PHYSICIAN DETERMINED THAT THE PT HAD DEVELOPED AN EPIDURAL HEMATOMA. THE HEMATOMA WAS REMOVED AND THE
WERE DISCARDED AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. EVALUATION: METHOD: THE DEVICE
MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD N
HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM D
REFERENCE MFR REPORT # 1627487-2010-04267. THE PT REC'D HER SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG AND
THAT THE PT HAD DEVELOPED AN EPIDURAL HEMATOMA. THE HEMATOMA WAS REMOVED AND THE PT'S SCS SYSTEM WAS EX
NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.
THE PATIENT WAS EXPLANTED AND IS REPORTEDLY DOING WELL. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS T
ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING. A REPO
LONGER USES THE SYS DUE TO NON-DEVICE RELATED PARALYSIS AND USES A WHEEL CHAIR. THE PT IS EXPECTED TO UNDERGO
THE POCKET SITE DURING HIS WHEEL CHAIR'S BACK AND FORTH MOVEMENT. THE PATIENT NO LONGER USES THE SYSTEM DU
SYSTEM. THE DEVICE IS WORKING PROPERLY.
A REPORT WAS RECEIVED THAT THE PT DEVELOPED A BLOOD CLOT FOLLOWING A PADDLE LEAD IMPLANT PROCEDURE. THE PT
AND THE PT IS DOING WELL. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FA
METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZA
COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED IN
THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. THE PATIENT RECEIVED HER
IMPLANT PROCEDURE, THE PHYSICIAN INSERTED THE METAL END OF THE DURAL SEPARATOR INTO THE PATIENT. AFTER THE IM
THE LEAD AFTER 20 MINUTES BUT DID NOT RETURN IT TO THE MANUFACTURER FOR EVALUATION. ON (B)(6) 2010, THE PHYSIC
NEUROLOGIST FELT THE EVENT WAS MYELITIS AND UNRELATED TO THE IMPLANT SURGERY. THE PATIENT IS BEING TREATED W
A REPORT WAS RECEIVED THAT A PATIENT HAD HER IPG EXPLANTED DUE TO HER DEVICE BEING SURGICALLY MISPLACED IN TH
(B)(4). THE PT EXPERIENCED PARALYSIS OF THEIR LEGS FOLLOWING IMPLANT. IT WAS DETERMINED THAT THE PT HAD A HEMA
ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
A REPORT WAS RECEIVED THAT FOLLOWING IMPLANT SURGERY, THE PT EXPERIENCED NUMBNESS IN HER LEGS AND PARALYSI
PATIENT'S LEAD. UPON EXPLANT SURGERY, THE PATIENT REGAINED SENSATION IN HER LEGS AND FEET. THE EXPLANTED LEAD W
(B)(4). THE PT EXPERIENCED PARALYSIS FROM THE CHEST DOWN. THE PARALYSIS WAS RELIEVED AFTER THE LEAD WAS EXPLAN
SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
(B)(4). (B)(4). INITIALLY, IT WAS REPORTED THAT AN ATTORNEY ALLEGED THAT A PT PRESENTED FOR "RE-INSERTION" OF AN SC
INVOLVED REPLACEMENT OF THE LEADS (PRESUMABLY REPLACEMENT OF REPORTING MFR LEADS WITH COMPETITOR LEADS)
RETURNED TO THE MFR FOR ANALYSIS. ADD'L INFO REC'D ON 10/08/2010 CLARIFIED THAT THE PT'S RESULTANT QUADRIPARES
STIMULATOR DEVICES. THE PT DEVELOPED WEAKNESS AND SENSORY CHANGES IN ALL EXTREMITIES, AND HAD NUMBNESS AR
DISCOMFORT WITH SITTING SECONDARY TO PLACEMENT OF THE DEVICE IN HER RIGHT UPPER BUTTOCK, AS WELL AS COSMET
TUNNEL SYNDROME. THE PT LATER UNDERWENT DECOMPRESSIVE SURGERIES, BUT DEVELOPED REFLEX SYMPATHETIC DYSTRO
PT'S STRENGTH OVER ALL WAS GREATER ON HER RIGHT SIDE IN BOTH THE UPPER AND LOWER EXTREMITIES. IN ADDITION, HE
LAMINECTOMIES, MICROSCOPIC INTRADURAL EXPLORATION, EXCISION OF SPINAL STIMULATOR LEAD, REPAIR OF CSF LEAK, AN
REVEALED THAT THERE WAS SLIGHT ENHANCEMENT OF THE MENINGES OF THE LOWER AND MID-CERVICAL REGION POSTERIO
SIGNIFICANT DISK HERNIATION, OR STENOSIS. POSTOPERATIVELY SHE WAS IN MODERATELY SIGNIFICANT PAIN, AND REMAINE
RHYTHM WITHOUT SIGNIFICANT ST OR T WAVE CHANGES. ON (B)(6) 2004, IT WAS NOTED PER PROGRESS NOTES THAT PHYSIC
ON (B)(6) 2004 THAT THE PT'S NEURO EXAM REMAINED UNCHANGED REGARDING QUADRIPARESIS, AND PAIN WAS BEING CON
(B)(6) 2004, THE PT WAS DISCHARGED HOME WITH THE RECOMMENDATION OF OUTPATIENT THERAPY, PHYSICAL THERAPY FIV
REASONABLY WELL DURING THE COURSE OF ACUTE REHABILITATION. THE NEUROPSYCHOLOGIST REPORTED THAT THE PT WAS
PROPEL MANUAL WHEELCHAIR, AND THEREFORE A POWER WHEELCHAIR WAS RECOMMENDED FOR MOBILITY. AN OCCUPATI
BATHING REQUIRED MAXIMAL ASSISTANCE. THE PT COMPLAINED OF HYPERSENSITIVITY TO WATER. IT WAS OBSERVED THAT T
COMPLAINTS. THE PT WAS DISCHARGED WITH THE FOLLOWING MEDICATIONS: BACTRIM DS, BACLOFEN (10 MG PO T.I.D.), CEL
(5% Q DAY), PROTONIX (40 MG Q DAY), K-DUR (20 MCQ Q DAY), VALPROIC ACID ELIXIR (400 MG QHS), AND NORCO 7.5 MG (ON
EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY A
REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS
HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. THE PATIENT RE
UP ON THE PATIENT FOUND THAT HE DID NOT HAVE PARALYSIS BUT INSTEAD HAD EXPERIENCED EXTREME MUSCLE SPASMS A
DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2010-02088. THE PT RECEIVED HER SCS SYSTEM INCLUDING TWO PERCUT
THAT THE LEADS MIGRATED AND THE PT LOST STIMULATION TO THE DESIRED AREAS. THE PT WAS REPROGRAMMED REPEATE
INFORMATION IS AVAILABLE. DEVICE 2 OF 2. EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEW
FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE D
AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MED
DEVICE 1 OF 2. EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF TH
NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RE
THE DHR AND STERILIZATION RECORDS. (B)(4). ANS HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND
REGARDING MEDICAL HISTORY. DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2010-02089. THE PT RECEIVED HER SCS SY
ONE SIDE. IT WAS REPORTED THAT THE LEADS MIGRATED AND THE PT LOST STIMULATION TO THE DESIRED AREAS. THE PT WA
EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
THE PT RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD AND AN IPG, ON 10/07/2010. PRIOR TO THE IMPLANT, THE PH
SUBSEQUENTLY, NO INTRA-OPERATIVE TESTING WAS PERFORMED. THE PHYSICIAN USED A DURAL SEPARATOR FROM THE HOS
FOR AN EXPLORATORY PROCEDURE. THE PHYSICIAN WAS UNABLE TO FIND ANY ABNORMALITIES. THE PT UNDERWENT ANOTH
POST-IMPLANT. F/U ON THE PT INDICATED THERE WAS NO IMPROVEMENT SINCE EXPLANT AND HE REMAINS PARALYZED FROM
NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE
ALLEGED DEVICE FAILURE. AN INCOMPLETE LEAD SEGMENT WAS RETURNED TO THE MFR FOR ANALYSIS. VISUAL ANALYSIS FOU
CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND S
OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
SHOKAT M, DOSANJH SS, CASTHELY D. A REPORT OF PARAPARESIS FOLLOWING SPINAL CORD STIMULATOR TRIAL, IMPLANTATI
AND REVISION IS UNK. FOUR PTS ARE PRESENTED WHO WERE ADMITTED TO AN ACUTE SPINAL CORD REHABILITATION HOSPI
FOLLOWING SUCCESSFUL IMPLANTATION (LEADS AT T8-9 LEVEL), THE PT DEVELOPED (3 DAYS POST-OP) WORSENING NUMBNE
RIGHT LOWER EXTREMITY. NEUROLOGICAL EXAMINATION AT THAT TIME REPORTEDLY REVEALED 2/5 STRENGTH THROUGHOU
IV STEROIDS. A 2-STAGE SURGICAL PROCEDURE WAS PERFORMED: STAGE 1 WAS A LEFT SIDED THORACOTOMY WITH DISCECTO
INSTRUMENTATION AND FUSION FROM T6 THROUGH T10. POST-OP THERE WERE NO ADD'L COMPLICATIONS BUT PT EXPERIEN
REHABILITATION 12 DAYS AFTER SURGERY. AFTER A 33 DAY STAY, A WHEELCHAIR AND ROLLING WALKER WAS NEEDED FOR AM
DISCHARGE (B)(6) EXAM WAS CONSISTENT WITH A T11 ASIA C SPINAL CORD INJURY. SEE MFR REPORT# 300756623720100763
SHOKAT M, DOSANJH SS, CASTHELY D. A REPORT OF PARAPARESIS FOLLOWING SPINAL CORD STIMULATOR TRIAL, IMPLANTATI
AND REVISION IS UNK. FOUR PTS ARE PRESENTED WHO WERE ADMITTED TO AN ACUTE SPINAL CORD REHABILITATION HOSPI
WAS IMPLANTED SUCCESSFUL; NO ACUTE POST OPERATIVE COMPLICATIONS. HOWEVER ON POST-OPERATIVE DAY #5; NEW AC
THERE WAS ASSOCIATED URINARY RETENTION. THE PT WAS TAKEN TO A LOCAL ED AND WAS TRANSFERRED THE SAME DAY TO
EPIDURAL HEMATOMA EXTENDING 2 LEVELS ABOVE THE AREA OF SPINAL CORD STIMULATOR PLACEMENT. ON POST-OP DAY #
COMPLICATIONS AND THE PT TOLERATED THE PROCEDURE WELL A F/U MRI OF THE THORACIC SPINE REVEALED CORD EDEMA
LEVEL FOR MANUAL WHEELCHAIR TRANSFERS, ACTIVITIES OF DAILY LIVING, BLADDER AND BOWEL PROGRAM. SEE MFR REPO
LITERATURE: SMITH CC, LIN JL, SHOKAT M, DOSANJH SS, CASTHELY D. A REPORT OF PARAPARESIS FOLLOWING SPINAL CORD ST
(B)(4) TRIAL, IMPLANTATION AND REVISION IS UNK. FOUR PTS ARE PRESENTED WHO WERE ADMITTED TO AN ACUTE SPINAL C
IMPLANTATION. EVENT: FOLLOWING SUCCESSFUL IMPLANTATION, THE PT EXPERIENCED SUDDEN LOW BACK PAIN; BILATERAL
REMOVED AND EMERGENT MRI OF THE LUMBAR SPINE WAS PERFORMED. DECOMPRESSIVE THORACIC AND LUMBAR LAMINE
DAYS AFTER HER DECOMPRESSIVE SURGERY. FOLLOWING ACUTE INPATIENT REHABILITATION STAY, PT RECOVERED FULL MOTO
FULL BLADDER AND BOWEL FUNCTION RECOVERY. HER DISCHARGE (B)(6) EXAM WAS CONSISTENT WITH A T7 ASIA D SPINAL C
TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD
EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AN
OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. A
THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY. ON (B)(6)2010, THE PT WAS IMPLA
ANOTHER LEAD. THE SECOND LEAD ALSO EXHIBITED HIGH IMPEDANCES, BUT THE DOCTOR LEFT THE LEAD IMPLANTED. ON (B
REP TURNED THE STIMULATOR OFF. THE DOCTOR TOLD THE PT THAT HE COULD USE THE STIMULATOR OVER THE WEEKEND, IF
PRESENTED WITH PAIN WHICH PROGRESSED TO PARALYSIS IN THE PT'S LOWER EXTREMITIES. THE SCS SYS WAS SUBSEQUENTL
EVALUATION: METHOD: ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. RESULTS: UPON VISUAL INSPECTION, PR
COMPRESSION DAMAGE WAS OBSERVED APPROXIMATELY 13.4CM FROM THE PADDLE. DISCOLORATION WAS ALSO OBSERVED
TESTING REVEALED THE RETURNED LEAD PASSED CONTINUITY AND STRESS TESTING. ALL CHANNELS MEASURED LESS THAN 4
TESTING. ALL CHANNELS MEASURED LESS THAN 4 OHMS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDIC
PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. DEVICE 2 OF 2. SEE MFR#1627487-2010-02672. ON (B)(6) 2010, THE PAT
EXPERIENCED SYMPTOMS OF SLIGHT PARALYSIS. THE PATIENT WENT TO THE HOSPITAL AND THE DOCTOR PLACED THE PATIENT
SITE. THE PATIENT WAS THEN TAKEN TO A LARGER MEDICAL FACILITY.
DEVICE 1 OF 2. SEE MFR#1627487-20100-02823. ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE PA
WENT TO THE HOSPITAL AND THE DOCTOR PLACED THE PATIENT INTO SURGERY. THE DOCTOR DECIDED TO REMOVE THE SCS S
FACILITY. EVALUATION: METHOD: ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. RESULTS: UPON VISUAL INSPE
DISCOLORATION WAS OBSERVED IN BOTH SEPTUM'S. DISCOLORATION WAS ALSO OBSERVED AT THE BOTTOM OF THE HEADER
TESTED ON THE AUTO-TESTER AND PASSED. CONCLUSION: THE COMPLAINT COULD NOT BE CONFIRMED FOR "SERIOUS INJUR
TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIE
ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE DOCTOR ASSESSED THE EPIDURAL SPACE USING MR
AND AROUND THE RIB CAGE, FOLLOWED BY NUMBNESS. THE DOCTOR ORDERED AN EMERGENCY CT SCAN AND LATER PERFOR
EPIDURAL HEMATOMA CAUSING SPINAL CORD COMPRESSION. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS
NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM
TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIE
DEVICE 3 OF 3. PLEASE SEE MFR REPORT 1627487-2010-02533 FOR DEVICE 1. PLEASE SEE MFR REPORT 1627487-2010-02675
AND WAS TAKEN TO THE EMERGENCY ROOM. THE PT COMPLAINED OF PAIN AT THE IPG SITE. THE PT IS ABLE TO INCREASE THE
(B)(6) 2010, IT WAS DETERMINED THAT THE PT'S LEADS MIGRATED. THE PT HAS FALLEN 3 TIMES IN 6 WEEKS. ON (B)(6) 2010, T
HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS W
COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED IN
REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
DEVICE 2 OF 3. PLEASE SEE MFR REPORT 1627487-2010-02533 FOR DEVICE 1. PLEASE SEE MFR REPORT 1627487-2010-02676
AND WAS TAKEN TO THE EMERGENCY ROOM. THE PT COMPLAINED OF PAIN AT THE IPG SITE. THE PT IS ABLE TO INCREASE THE
(B)(6) 2010, IT WAS DETERMINED THAT THE PT'S LEADS MIGRATED. THE PT HAS FALLEN 3 TIMES IN 6 WEEKS. ON (B)(6) 2010, T
HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS W
FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTOR
REGARDING MEDICAL HISTORY.
EVAL: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZ
REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS
EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY. DEVICE 1 OF 3. PLEASE SEE MFR REPOR
SCS SYSTEM. IT WAS REPORTED THAT THE PT FELL BACKWARDS IN HER WHEELCHAIR AND WAS TAKEN TO THE EMERGENCY RO
AND THEN TURNS ITSELF OFF. THE PT REPEATED THIS PROCESS MULTIPLE TIMES. ON (B)(6)2010, IT WAS DETERMINED THAT TH
LEADS WERE REPLACED WITH A PENTA PADDLE LEAD.
EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY A
REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MD
INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REG
TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDIN
REPORTED THAT THREE DAYS LATER, THE PATIENT WAS PARALYZED, WITH NO FEELING OR MOVEMENT IN EITHER LEG. THE PAT
EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PATIENT FOUND THAT AS OF (B)(6) 2
ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY TO BE IMPLANTED WITH AN SCS SYSTEM. THE PHYSICIAN COULD NOT GE
THERE WAS A SPINAL TAP. THE CASE WAS ABORTED AFTER THAT AND THE LEADS WERE DISCARDED. ON (B)(6) 2010, THE REP R
EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY A
CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECO
THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
EVAL: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION
DAMAGE WAS NOTED AT THE TERMINAL END ELECTRODE. THE LEAD ALSO HAD COMPRESSION DAMAGE. THE LEAD WAS FUNC
TERMINAL END ELECTRODE. CONCLUSION: THE CAUSE OF THE REPORTED PARALYSIS COULD NOT BE CONFIRMED. THE LEAD A
PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REP
REPORTED THAT IMMEDIATELY FOLLOWING THE OPERATION THE PT SUFFERED PARALYSIS OF BOTH LEGS AND AN ERECTION. T
IN THE LEFT LEG AND THE DOCTOR DECIDED TO TAKE AN MRI, WHICH RESULTED IN THE SYSTEM BEING EXPLANTED.
THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECO
COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION
ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SY
SUBSEQUENTLY PLACED IN REHAB. THE PT HAS REGAINED SOME USE OF HER RIGHT HAND. THE SYSTEM IS STILL IMPLANTED.
ON (B) (6)2010, THE PT WAS IMPLANTED WITH A SCS SYSTEM. POST OPERATION, THE PT WAS ONLY ABLE TO FEEL THE STIMUL
OF THE RIGHT LEG. THE CAUSE OF THE PARALYSIS WAS DETERMINED TO BE A HEMATOMA. THE PT WAS TAKEN BACK TO THE O
RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANO
PERFORMED ON THE INCOMPLETE LEAD. THE LEAD PADDLE WAS MEASURED AND IS WITHIN DRAWING SPECIFICATION. CONC
MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORT
ON (B) (6) 2009, THE PT WAS IMPLANTED WITH A SCS SYSTEM. THE FOLLOWING DAY, THE PT WAS DISCHARGED WITH SEVERE
UNHAPPY WITH THE STIMULATION BECAUSE IT CANNOT BE FELT WHERE NEEDED; THE PT IS CONSIDERING HAVING THE DEVIC
REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REP
(B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD AND SYSTEM CHANGE OUT ON (B)(6) 2004. SHE HAD A PRIO
PARALYSIS POST SURGERY (SEE MANUFACTURER REPORT 6000153200600293) AND NOTED THAT THE DEVICE BROKE SHORTLY
PROGRAMMING DID NOT RESOLVE ISSUE AND SHE DID NOT WANT TO HAVE ANYTHING ELSE DONE WITH THE SYSTEM. SHE RE
ON THE RIGHT SIDE. SHE HAD NOT REGAINED FULL STRENGTH AND FEELING SENSATION WAS STILL POOR ESPECIALLY ON THE
HAVE THE DEVICE REMOVED. SHE WAS AT HOME IN FAIR CONDITION.
PATIENT HAD SPINAL CORD STIMULATOR IMPLANTED ON (B) (6) 2009. IN RECOVERY ROOM, THE PATIENT BEGAN EXPERIENCIN
PARAMEDICS WERE CALLED, AND PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. A CT SCAN REVEALED AN EPIDURA
WAS CAUSED BY AN ALLEGED MALFUNCTION OF THE INSULATION ON THE LEADS OF THE DEVICE, CAUSING DAMAGE TO THE S
IT WAS REPORTED THAT DURING AN SCS IMPLANT PROCEDURE, AS THE PHYSICIAN WAS PLACING THE LEADS, NEUROMONITO
PT STEROIDS. WHEN THE PT AWAKENED, SHE HAD SOME MOVEMENT ON THE LEFT SIDE. AS OF (B) (6) 2010, THE PT'S PARALYS
REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS A
DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM
EVALUATION, METHOD: - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: - THE DEVICE HISTOR
THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS
INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REG
THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL H
PT WAS NOTICING HER IPG RANDOMLY SHUTTING OFF ON ITS OWN BEGINNING ON (B) (6) 2009. THE PT HAD NOT HAD ANY FA
IPG WAS EXPLANTED ON (B) (6) 2009 AND ANOTHER LEAD WAS ADDED TO HER SYSTEM. THE EXPLANTED IPG WAS NOT RETUR
(B) (4) PATIENT HAD SURGERY RELATED TO HIS PARALYSIS AND THE SURGICAL LEAD AND EXTENSIONS WERE REMOVED AND D
PATIENT WAS REPORTED, HE RECOVERED WITHOUT SEQUELA.
COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION
REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. IT WAS REPORTED THAT WHEN THE SAL
EPIDURAL BLEEDING AND SHOWED SIGNS OF PARALYSIS. THE LEAD WAS EXPLANTED.
THE PATIENT EXPERIENCED LEG DISTRESS IMMEDIATELY DURING THE TRIAL. HIS LEGS JUMPED AND THE PROCEDURE WAS UNC
PULLED. POST PULLING THE LEADS OUT, HE EXPERIENCED NUMBNESS OF LEGS, MAINLY LEFT AND PARTIAL RIGHT. AN MRI AND
(B)(4). THE PT HAS LOST WEIGHT SINCE BEING IMPLANTED AND HER NEUROSTIMULATOR (INS) MOVES AROUND. SHE DOES NO
THE STIMULATION WAS MORE BOTHERSOME THAN THE PAIN ITSELF. SHE HAS FACIAL PARALYSIS ON HER LEFT SIDE OF HER EA
TO WORK ON A RESOLUTION. ADDITIONAL INFO HAS BEEN REQUESTED. (B) (4). ADDITIONAL INFORMATION WAS RECEIVED ON
DID A TRIAL AND THOUGH THEY COULD GET USED TO THE STIMULATION BUT DID NOT. IT WAS NOTED THAT THE PATIENT'S LE
THE KNEE REPLACEMENT AND STIMULATOR. IN (B)(6) 2010 THE PATIENT STARTED TO TURN THE STIMULATOR ON AND TURNED
COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED
DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY. DEVICE 2 OF 2. SEE MFR REPORT NUMBER 1627487-2010-000
IMPLANTED THE IPG. THE PROCEDURE WAS UNEVENTFUL. IN THE RECOVERY ROOM, THE PT EXPERIENCED PARALYSIS IN BOTH
CAUSED THE PARALYSIS.
DEVICE 1 OF 2. SEE MFR REPORT NUMBER 1627487-2010-00087 FOR DEVICE 2. IT WAS REPORTED THAT DURING A REVISION S
RECOVERY ROOM, THE PT EXPERIENCED PARALYSIS IN BOTH LEGS. THE STIMULATOR WAS NOT TURNED ON. THE DOCTOR REM
RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET S
REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS U
MEDICAL HISTORY.
EVALUATION: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZAT
THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. THE PATIENT RECEIVED HER
ANESTHESIA FROM THE PROCEDURE AND WAS MOVED TO A REHABILITATION FACILITY ON (B) (6) 2010. HE SAID THAT TWO DA
CORD INFARCTION. IT WAS REPORTED THAT NO ANOMALIES OCCURRED DURING PLACEMENT OF THE PADDLE LEAD OTHER TH
REPORTED THAT INTRA-OPERATIVELY THE HEAD OF THE BED WAS ELEVATED TO ALLOW MORE DISTAL MOVEMENT OF THE SPI
OF HER UPPER EXTREMITIES. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.
EVALUATION: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZAT
THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. IT WAS REPORTED THAT THE
THE RIGHT SIDE. ON (B) (6) 2010, THE PHYSICIAN MADE A LARGER LAMINECTOMY AND USED A DURAL SEPARATOR TO OPEN T
IN BOTH LEGS, AND WAS SENT HOME. AT HOME DURING THE AFTERNOON, THE PATIENT STOOD UP, AND COULD NOT FEEL TH
LEGS AT THE HOSPITAL. THE CT SCANS WERE NEGATIVE AND NO HEMATOMA WAS OBSERVED. IT WAS REPORTED THE PHYSICIA
THE PT EXPERIENCED NO STIMULATION FOLLOWING A CT SCAN. SHE HAD TO WIGGLE HERSELF INTO A WHEELCHAIR THAT WA
IMPLANT ON AND OFF BUT WAS NOT ABLE TO INCREASE/DECREASE STIMULATION. THE NEUROSTIMULATOR (INS) WAS "NOT W
IMPLANT WAS IN A PERPENDICULAR POSITION RELATIVE TO BEFORE SHE SAT IN THE WHEELCHAIR. SHE HAS AN APPOINTMEN
THE PT WAS IMPLANTED WITH A LEAD, EXTENSIONS, AND IPG ON (B) (6) 2008. IT WAS REPORTED THAT POSTOPERATIVELY, TH
REMAINED IMPLANTED AND THE PT SENT TO OUTPATIENT REHABILITATION. IT WAS REPORTED THAT THE DURA MAY HAVE BE
ADMITTED TO THE HOSPITAL TO TREAT AN INFECTION BUT THE SCS SYSTEM REMAINS IMPLANTED. DEVICE HISTORY AND STER
AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED F
RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD
DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS
COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED P
REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. A
THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY. THE PT RECEIVED HER TRIAL SCS S
UPON TURNING IT BACK ON FELT OVERSTIMULATION IN HER CHEST AND SHOULDER. IT WAS REPORTED THAT THE PT SAW THE
AFTERWARDS, THE PT EXPERIENCED WEAKNESS IN HER LEGS AND WAS DAZED AND CONFUSED. ON (B) (6) 2008, IT WAS REPO
2008, THE PT REPORTEDLY COULD NOT FEEL HER LEGS, EXPERIENCED LOSS OF BLADDER CONTROL, AND WAS IN SEVERE PAIN
FOUND A HEMATOMA FROM S1 TO C4. AFTER THE PROCEDURE, THE PT STILL HAD PARALYSIS IN HER RIGHT LEG BUT COULD M
DEVICE 1 OF 3. DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZA
COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. LEAD HAS A SHARP
THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION
REPORTS: 1627487-2009-00263 AND 1627487-2009-00264. THE PT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG AND TW
DOWN. THE PHYSICIAN EXPLANTED THE PT'S SYSTEM ON (B) (6) 2008. IT WAS REPORTED THAT THE PT IMMEDIATELY REGAINE
DEVICE 2 OF 3. DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZA
COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. LEAD HAS A SHARP
THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION
REPORTS: 1627487-2009-00262 AND 1627487-2009-00264. THE PT REC'D HIS SCS SYSTEM CONSISTING OF AN IPG AND TWO L
DOWN. THE PHYSICIAN EXPLANTED THE PT'S SYSTEM ON (B) (6) 2008. IT WAS REPORTED THAT THE PT IMMEDIATELY REGAINE
DEVICE 3 OF 3. REFERENCE MFR'S REPORTS: 1627487-2009-00262 AND 1627487-2009-00263. THE PT RECEIVED HIS SCS SYSTE
COMPLETE PARALYSIS FROM THE WAIST DOWN. THE PHYSICIAN EXPLANTED THE PT'S SYSTEM ON (B) (6) 2008. IT WAS REPORT
AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WER
DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY
COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS HAS LIMITED
EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
THE PT RECEIVED HER SCS SYSTEM CONSISTING OF ONE LEAD AND AN IPG ON (B) (6) 2009. IT WAS REPORTED THAT POSTOPER
NEARBY TISSUE. IT WAS REPORTED THAT ON (B) (6) 2009, THE PHYSICIAN MOVED THE LEAD BACK INTO THE ORIGINAL EPIDUR
MANUFACTURER BY VOICEMAIL THAT THE REASON THE LEAD WAS MOVED ON (B) (6) 2009 WAS BECAUSE SHE EXPERIENCED N
AND FEET WERE STILL NUMB. THE MANUFACTURER ATTEMPTED TO CONTACT THE PT WITH NO SUCCESS. THERE IS NO FURTH
RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE O
SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO A
INSTANCE. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE
(B) (4). DURING IMPLANT THE PHYSICIAN WENT TO THE OTHER SIDE OF THE PT AND TRIED TO CREATE ANOTHER LAMINOTOM
WAS ABORTED. ANY TREATMENTS THE PT RECEIVED ARE UNK. THE OUTCOME IS UNK. FURTHER INFO IS BEING REQUESTED FR
A REPORT WAS RECEIVED THAT FOLLOWING AN EXPLANT PROCEDURE, DUE TO THE PATIENT NEEDING ANOTHER PROCEDURE,
FOR THE PARALYSIS IS CURRENTLY NOT AVAILABLE. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED B
POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. A REVI
THE EVENT OCCURRED DURING MANUFACTURING. THIS IS THE FINAL REPORT. A REPORT WAS RECEIVED THAT A PATIENT WAS
PHYSICIAN DID NOT THINK THE PARALYSIS WAS DEVICE RELATED BUT RATHER IT WAS RELATED TO THE PATIENT'S ANATOMY. TH
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONE EPISODE OF PARALYSIS OF THE LEGS (30 MINUTES); THIS OCCURRED
SYSTEM WAS REPORTED TO BE OFF AT THAT TIME. CT SCAN RESULTS WERE NEGATIVE; ADDITIONAL TESTING (UNSPECIFIED) D
BEEN REQUESTED, A FOLLOW-UP WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. .
A REPORT WAS RECEIVED THAT A PT WAS EXPERIENCING TEMPORARY PARALYSIS AND NUMBNESS IN BOTH OF HER LEGS THAT
A REPORT OF A TRIAL PT DEVELOPING PARALYSIS IN HER LEG WAS RECEIVED. THE PT WAS NOT ABLE TO MOVE HER LEG. THE P
DEVICE RELATED.
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING PARALYSIS OF HIS RIGHT ARM.
A REPORT WAS RECEIVED THAT THE PT UNDERWENT A POCKET REVISION DUE TO THE PT DEVELOPING A HEMATOMA OVER H
MOVED THE POCKET SITE FROM THE PT'S BACK SIDE TO THE STOMACH AREA. THE PT IS REPORTEDLY DOING WELL. THIS IS THE
A REPORT WAS RECEIVED THAT A PT WAS EXPLANTED DUE AN EPIDURAL HEMATOMA AFTER UNDERGOING A PROCEDURE TO
(B)(4). THE PT WAS IN A WHEELCHAIR, AND ONCE DURING A TRANSPORT, HIS WHEELCHAIR HIT A POTHOLE, TIPPED BACKWAR
(SCRAPES) AROUND THE INS POCKET SITE. SINCE THEN, WHILE THE STIMULATION WAS ON, THE PT WAS EXPERIENCING A SUR
DURING RECHARGING WAS FLUCTUATING BETWEEN 8 AND 2 BARS EVEN THOUGH HE WAS STAYING VERY STILL WHILE RECHAR
F/U WITH THE PT'S HEALTHCARE PROVIDER WAS RECOMMENDED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE
BOWEL AND BLADDER DYSFUNCTION. THE ATTORNEY ALLEGES "THE PATIENT WAS IMPLANTED WITH A PERMANENT SPINAL C
AND CONTRIBUTING TO SPINAL CORD INJURY (RESULTING IN FLACCID PARALYSIS OF HER RIGHT LEG, WEAKNESS IN HER LEFT
TO TURN THE DEVICE ON OR OFF.
A REPORT WAS RECEIVED THAT SHORTLY AFTER IMPLANT, THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA. THE PATIENT'S
PHYSICIAN REMOVED THE CLOT SUCCESSFULLY. THE PHYSICIAN BELIEVES THAT THE HEMATOMA IS NOT DEVICE RELATED. FURT
ASPIRIN SOON ENOUGH. THE PATIENT WAS HOSPITALIZED AND WAS RE-IMPLANTED. THE PATIENT IS REPORTEDLY DOING WEL
A REPORT WAS RECEIVED THAT A PT WILL HAVE THE PRECISION SYSTEM EXPLANTED BECAUSE OF CERVICAL COMPRESSION DU
CONFINED TO WHEELCHAIR. THE PT'S LEAD IS PLACED HIGH IN THE CERVICAL SPINE, AND THERE IS CONCERN THAT THE PT MI
THE PT HAD A BLOOD CLOT ASSOCIATED WITH LEAD REVISION SURGERY THAT RESULTED IN PARALYSIS. THE PT'S CURRENT STA
(B) (4). THE LEAD WAS REPORTED TO BE FRACTURED. THE PHYSICIAN COMMENTED THAT THE PT WAS IN A WHEELCHAIR AND
IN 2009, I RECEIVED A MEDTRONIC NEUROSTIMULATOR. THIS WAS A TEMPORARY DEVICE FOR THE SCREENING PERIOD. I WAS
ORIGINAL DATE. AT THIS APPOINTMENT WITH THE MEDTRONIC REPRESENTATIVE, I INFORMED HER THAT I WAS EXPERIENCING
DISCOMFORT- WAS LIKELY CAUSED BY THE INCISIONS HEALING. I INFORMED HER THAT I HAVE HAD NUMEROUS SURGERIES AN
SECURE THE DEVISE. THE NURSE ASSURED ME THAT WAS NOT THE CASE BECAUSE THEY WERE AWARE OF MY ADHESIVE ALLER
DEVICE TO A LEVEL THAT WAS COMFORTABLE TO ME AND GAVE ME FURTHER INSTRUCTIONS OF THE USE OF THE DEVICE, HER
APOLOGIZED FOR THE LATENESS OF THE CALL, BUT I WAS STILL EXPERIENCING DISCOMFORT AND IT WAS GETTING WORSE. SH
THAT EVENING OR THE FOLLOWING DAY. I CALLED THE DOCTOR AGAIN. NO CALL WAS RETURNED. I WENT TO URGENT CARE T
SHE WOULD BE WILLING TO GIVE ME PREDNISONE FOR THE ITCHING AND DISCOMFORT. SHE ALSO INSTRUCTED ME NOT TO G
-FIVE DAYS AFTER THE ORIGINAL DATE-, REP CALLED TO FOLLOW-UP ON MY RETURN CALL TO HER REGARDING NO PHONE CAL
HOUR LATER INSTRUCTING ME TO COME AT 7AM THE NEXT DAY, SO THE NEUROSTIMULATOR COULD BE REMOVED. ON THAT D
ME WAS THE LEADS WERE SUPPOSE TO LOOK LIKE AND THAT IT HAD NEVER HAPPENED BEFORE -PIECES OF THE DEVICE LEFT I
MORNING, TWO DAYS LATER. I ARRIVED, WAS PREPPED WITH AN IV AND POSITIONED ON THE TABLE. ANOTHER MEDTRONIC'S
EXCLAMATIONS OF "I'VE NEVER SEEN ANYTHING LIKE THIS", AND "HOW DID THAT HAPPEN" WERE BEING MADE. I EXPRESSED
OVER THE AREA AND LIFT THE ELECTRODES OUT, BUT THE LEADS HAD TWISTED AROUND AND THE END WAS CURLED WHICH
SURGERY TO REMOVE THE LEFT OVER DEVICE AND IMPLANT THE PERMANENT ONE AT THE SAME TIME SO I WOULD NOT HAV
PARALYZED BECAUSE IT WAS LEFT IN UNTIL SURGERY TO REMOVE IT. HE AND THE OTHERS IN THE ROOM ASSURED ME THAT T
HAPPENED IN HIS 23 YEARS OF PRACTICE BY DR. THE MEDTRONIC REP SAID, HE HAD NEVER HEARD OF AN INCIDENT LIKE THIS
HOWEVER, I'M NOT SCHEDULED FOR REMOVAL OF THIS THING UNTIL EARLY OF THE FOLLOWING MONTH. THE HOSPITAL WAS
HAD TO SEE TO APPROVE THE SURGERY WAS NOT INFORMED. THIS INCIDENT NEEDS TO BE RECORDED AND A REPORT FILED. T
. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL WHILE PUSHING THEIR SISTER IN A WHEELCHAIR. PATIENT WAS U
PROGRAMMER. A LONGEVITY ESTIMATE REVEALED A 3 MOS BATTERY LIFE. ADDITIONAL INFORMATION RECEIVED REPORTED T
STIMULATOR. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WILL UNDERGO AND EXPLANT OF THEIR IMPLANTABLE NE
IT WAS REPORTED THAT THE PT EXPERIENCED A BLOOD CLOT THAT CAUSED A SPINAL STROKE AND PARALYSIS FIVE DAYS AFTE
FACILITIES. .
THIS IS THE FINAL REPORT. A REPORT OF A PATIENT EXPERIENCING POCKET SITE DISCOMFORT WAS RECEIVED. THE PATIENT IS
ABDOMEN AREA. THE PATIENT IS REPORTEDLY DOING WELL.
IT WAS REPORTED THAT THE SYSTEM WAS REMOVED THE DAY AFTER IMPLANT BECAUSE, IT DID NOT WORK. THE PATIENT HAD
"RUBBERY RIGHT FOOT". SHE WAS IN THE HOSPITAL FOR SIX DAYS. SHE COULD WALK WITH A WALKER BUT STRUGGLED. AT TH
INFORMATION IS BEING REQUESTED FROM THE HCP. .
A REPORT WAS RECEIVED THAT THE PATIENT HAD HER PRECISION SYSTEM EXPLANTED DUE TO PAIN AND LOSS OF FEELING IN
SPINAL CORD, CAUSING THE PAIN AND TEMPORARY PARALYSIS. AFTER THE EXPLANT, THE PATIENT IS ABLE TO FEEL HER LEGS A
MEDICAL FACILITY. THIS IS THE FINAL REPORT.
. THE PATIENT EXPERIENCED ABDOMINAL PAIN THE NIGHT OF IMPLANTABLE NEUROSTIMULATOR IMPLANT. HE WENT TO THE
EVENING (SPECIFICS NOT REPORTED). THE NEXT MORNING, THE PATIENT WAS STILL UNABLE TO URINATE. THE PATIENT REGAIN
DEVICE WAS REPROGRAMMED, AND THE PATIENT WAS GETTING GOOD STIMULATION COVERAGE. NO SURGERY WAS DONE. A
BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
REPORTED INCIDENT -- IN 2009, AN ANS SALES REP WAS ADVISED BY A PAIN DR THAT A FORMER PATIENT'S SYSTEM WAS EXPL
MEDICAL NOTE STATING THE SIZE OF THE LEAD MAY HAVE CONTRIBUTED TO THE SPINAL COMPRESSION, WHICH CAUSED PAR
OBTAINED. INVESTIGATION -- THE NEXT DAY, REP TALKED TO IMPLANT DR WHO MENTIONED THE PATIENT FELL AND HIT HIS HE
EXPLANT MD'S OFFICE; THE EXPLANT WAS PERFORMED ON THE MONTH PRIOR TO ORIGINAL MONTH. THE PATIENT EXPERIEN
DAYS AFTER THE ORIGINAL DATE, ANS CUSTOMER SUPPORT TALKED TO THE EXPLANT DOCTOR'S NURSE WHO STATED THE INC
WOULD PROVIDE ANS WITH ANY OTHER INFO NEEDED. BACKGROUND -- PATIENT HAD AN IPG AND SURGICAL LEAD IMPLANTE
APPOINTMENT WAS SCHEDULED TO PROGRAM THE IPG, BUT THE PATIENT MISSED THE APPOINTMENT. VARIOUS ATTEMPTS W
AND ADVISED HIM THAT HE MOVED TO ANOTHER STATE AND STATED HE NEEDED A LOCAL REP. THE PATIENT CONNECTED WIT
BOTH SESSIONS. THE NEW REP STATED THE PATIENT MENTIONED POST SURGICAL PAIN, AND HE ADVISED THE PATIENT TO GO
FOUND. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: DEVICE NOT RETURNED. TH
EVALUATION: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. RESULT
COULD NOT BE DETERMINED FROM THE REVIEW OF THE DEVICE HISTORY RECORD AND STERILIZATION RECORD. ANS INC. HAS
THE EVENT REPORTED. ANS INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY. IN 2009, IT WAS REPORTED T
REVISED THE MONTH PRIOR TO ORIGINAL DATE. DURING THE REVISION, THE PHYSICIAN REMOVED THE PERCUTANEOUS LEAD
RETURNED FOR EVAL. IT WAS REPORTED NO MRI WAS PERFORMED TO CONFIRM THE SPACE BEFORE SURGICAL LEAD REVISION
DISCARDED. IT WAS REPORTED A CT MYELOGRAM WAS PERFORMED. ONE PHYSICIAN STATED THERE WAS A HEMATOMA, AND
EXPLANTED SYSTEM WAS DISCARDED AND NOT RETURNED FOR EVAL. THREE DAYS AFTER THE ORIGINAL DATE, IT WAS REPOR
PHYSICIAN WILL BE PROVIDED WHEN OBTAIN.
IT WAS REPORTED THE PT LOST STIMULATION SUDDENLY. IMPEDANCE VALUES WERE HIGH BUT NOT OUT OF RANGE. THE BAT
CHANGED WITH NO RESULTS. AN X-RAY WAS DONE WHICH SHOWED NO LEAD FRACTURES OR MIGRATIONS. NO DEVICE EXPLA
A WHEELCHAIR (BOTH BEFORE AND AFTER THE STIMULATION STOPPED). .
. IT WAS REPORTED THE PT LOST STIMULATION SUDDENLY. IMPEDANCE VALUES WERE HIGH BUT NOT OUT OF RANGE. THE BAT
WAS CHANGED WITH NO RESULTS. AN X-RAY WAS DONE BUT THE RESULTS WERE UNK AT THE TIME OF THIS REPORT. NO DEVI
PT USES A WHEELCHAIR (BOTH BEFORE AND AFTER THE STIMULATION STOPPED).
A COMPLAINT WAS RECEIVED THAT A PATIENT HAD NO FEELING IN HER LEGS SINCE HER SURGERY IN 2009. THE PHYSICIAN PER
STIMULATION IN HER LOWER BACK, BUT NOT IN HER LEGS AFTER THE PROCEDURE. THE PHYSICIAN TRANSFERRED THE PATIEN
IT WAS REPORTED PATIENT HAD A SUCCESSFUL TRIAL WITH A SINGLE PERCUTANEOUS LEAD FOR LOWER BACK/LEFT LEG PAIN.
LEAD. PHYSICIAN ABORTED CASE AND REFERRED PT TO NEUROSURGEON. IT WAS REPORTED A LAMINOTOMY PROCEDURE WA
T10-T11; AFTER SEVERAL ATTEMPTS, THE NEUROSURGEON CHANGED LEAD TO A LAMITRODE NARROW TRIPOLE SURGICAL LE
WATCHING THE SSEP (SOMATOSENSORY EVOKED POTENTIALS) MONITOR STATED PT LOST LEG FEEDBACK; SURGEON ABORTED
STILL EXPERIENCING PARALYSIS IN RIGHT LEG AND IS IN REHAB FACILITY. IT WAS REPORTED THE EXPLANTED SYSTEM WAS DISC
REVIEWED WERE FOUND TO MEET SPECIFICATION. ANS INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND,
SPINAL CORD STIMULATION WAS ATTEMPTED THE DAY AFTER IMPLANTABLE NEUROSTIMULATOR IMPLANT. THERE WAS NO R
SEVERAL TIMES AND WAS THROWN FROM HIS WHEELCHAIR. PATIENT INJURIES INCLUDED A FRACTURE TO THE RIGHT FEMUR
AFTER THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBM
PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
IT WAS REPORTED THE PATIENT LOST STIMULATION SENSATION FOLLOWING A FALL. THE PATIENT FELL OUT OF A WHEELCHAIR
REPORT. .
. THE IMPLANTABLE NEUROSTIMULATOR TURNED OFF BY ITSELF. THE PT EXPERIENCED PARALYSIS IN HER LEG AND A LOSS OF T
INCIDENT OR ACCIDENT RELATED TO THIS COMPLAINT. THE PT WAS SITTING IN A DENTAL OFFICE CHAIR. SHE EXPERIENCED A S
'GOOD'. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILAB
DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00041 FOR DEVICE 2). PATIENT WAS IMPLANTED
PRESCRIPTION FOR PAIN AND INFLAMMATION. IT WAS REPORTED NEXT DAY, PATIENT WENT TO HOSPITAL IN EXTREME PAIN, N
EVALUATION. EVALUATION FOR DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00041 FOR EVA
ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: DEVICE NOT RETURNED. THE CAUSE OF THE
LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO T
. IT WAS REPORTED THE PATIENT FELT AN OVERWHELMING FEELING OF PARALYSIS. THE PATIENT WENT TO THE EMERGENCY R
REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
. FOLLOWING A LEAD REVISION (SEE MFR'S REPORT # 3004209178-2008-06213), THE PT REPORTED STIMULATION IN THE WRO
SYNDROME. THE STATED THAT IT FELT LIFE A KNIFE AND IT HURT TO BREATH. THE PT'S SYMPTOMS WERE LOCATED IN HER MID
PROFESSIONAL (HCP) STATED THAT HER PAIN WAS POST LAMINECTOMY SYNDROME; HOWEVER, THE PT DIDN'T BELIEVE THIS B
OFFERED TO DO A FOUR HOUR SURGERY TO TRY AND FIX THE LEAD, BUT THE PT STATED SHE DID NOT WANT TO DO THAT. SHE
BE "FAIR". ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IN ADD'L INFO BECOMES AVAILABLE.
IT WAS REPORTED A TRIAL PT EXPERIENCED PARALYSIS OF BOTH LEGS AND AN EPIDURAL HEMATOMA WAS SUSPECTED. THE L
CAUSED THE BLEED WHEN IT WAS BEING ADVANCED. THE TRIAL PROCEDURE WAS 'NORMAL? AND NO INDICATION OF ANYTH
TO HAVE PARTIAL PARALYSIS IN BOTH LEGS ONE WEEK LATER. NO FURTHER OUTCOME WAS REPORTED. A FOLLOW-UP REPORT
DEVICE 1 OF 2 (REFER TO MFR'S REPORT NUMBER 1627487-2008-00027 FOR DEVICE 2). THE PT WAS IMPLANTED WITH A SCS
OFFICE VISIT TO TURN STIMULATION ON. THE PT ARRIVED IN A WHEELCHAIR FOR THE APPOINTMENT AND PT STATED HE COU
THE PT'S LEG WEAKNESS WAS CAUSED BY NERVE COMPRESSION AND THAT THE SURGERY DID ADD TO THE COMPRESSION OF
DECOMPRESS THE NERVE AND THAT THE LEAD WAS NOT EXPLANTED AS PLANNED. PT REMAINS IN THE HOSP UNTIL PHYSICAL
1627487-2008-00027 FOR DEVICE 2). DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL R
COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DEVICE HISTORY RECORD AND STERILIZATION RECORD. A
TO THE EVENT REPORTED. ANS, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
EVAL RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE DEVICE IS STIL
STERILIZATION RECORD. ANS, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN O
DEVICE 2 OF 2 (REFER TO MFR'S REPORT NUMBER 1627487-2008-00026 FOR DEVICE 1). THE PT WAS IMPLANTED WITH A SCS
OFFICE VISIT TO TURN STIMULATION ON. THE PT ARRIVED IN A WHEELCHAIR FOR THE APPOINTMENT AND PT STATED, HE COU
THE PT'S LEG WEAKNESS WAS CAUSED BY NERVE COMPRESSION AND THAT THE SURGERY DID ADD TO THE COMPRESSION OF
DECOMPRESS THE NERVE AND THAT THE LEAD WAS NOT EXPLANTED AS PLANNED. PT REMAINS IN THE HOSP UNTIL PHYSICAL
FOLLOWING IMPLANT SURGERY, THE PT LOST SENSATION AND DEVELOPED PROFOUND WEAKNESS IN BOTH LEGS. THE DEFICIT
OR PUT PRESSURE ON THE SPINAL CORD. THE LEAD WAS IMPLANTED AT T8-T9; THE EPIDURAL SPACE WAS LARGE. THE HCP BE
COMPLICATIONS. THE PT WAS ADMITTED TO THE HOSPITAL AND TREATED WITH INTRAVENOUS IMMUNOGLOBULIN. THE HCP
STIMULATION WAS TURNED OFF. THE PT ALSO EXPERIENCED SEVERE ABDOMINAL BLOATING POST-SURGICALLY, WHICH DISSIP
WAS PROGRESSING TO THE UPPER QUADRANT. THE HCP TREATED THE SYMPTOMS AS A POSSIBLE VIRAL COMPLICATION. THE
EPIDURAL SPACE AND PLACED SUBCUTANEOUSLY IN HOPES OF REPLACE IT LATER IN THE EPIDURAL SPACE. FOUR DAYS AFTER I
ARTERIOGRAM WERE COMPLETED (RESULTS NOT REPORTED). EIGHT DAYS AFTER IMPLANT, THE PT CONTINUED TO BE HOSPIT
. IT WAS REPORTED THE PT HAD A TRIAL LEAD PLACEMENT PUT IN FOR RIGHT HAND PAIN. PLACEMENT WAS REPEATED SEVER
RIGHT SIDED WEAKNESS. THE HCP OPTED TO TAKE THE PT BACK TO SURGERY AND REMOVE THE LEAD. THE PT WAS DISCHARG
AVAILABLE.
IT WAS REPORTED THE PT SUFFERED TEMPORARY ARM PARALYSIS FOLLOWING HER IMPLANT. THE PT WAS SCHEDULED FOR E
EXTENSION WAS EXPLANTED. THE NEUROSTIMULATOR REMAINED IMPLANTED FOR FUTURE PAIN RELIEF. THE PHYSICIAN PLUG
THE DATE OF THIS REPORT. THE LEAD AND EXTENSION WERE RETURNED TO MFR FOR ANALYSIS. ANALYSIS RESULTS WERE NOT
. IT WAS REPORTED A PATIENT UNDERWENT A SPINAL CORD STIMULATION TRIAL WITH THE LEAD PLACED TO THE T3 LEVEL. A
PATIENT DEVELOPED AN EPIDURAL HEMATOMA WITH PARALYSIS. THE PATIENT WAS ADMITTED WITH RESOLUTION OF THE PA
AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS REPORTED A BLOOD CLOT FORMED DURING REVISION SURGERY FOR AN INFECTION. THE PHYSICIAN "FORCED THE LEA
EXTENT OF DAMAGE. THE PT CURRENTLY RESIDES IN A NURSING HOME. THE PT OUTCOME HAS NOT BEEN REPORTED. ADD'L I
2008-02641. .
IT WAS REPORTED THAT THE PT STATUS IMMEDIATELY FOLLOWING SYSTEM PLACEMENT WAS ACCEPTABLE; THE PT HAD DETEC
LEGS AND PARALYSIS OF THE LOWER EXTREMITIES WAS DIAGNOSED. AN MRI EXAM WAS SCHEDULED. THE PT WAS RETURNED
THEN REMOVED AND THE PULSE GENERATOR REMAINED IMPLANTED. THE FOLLOWING DAY, RESULTS OF MRI EXAM HAD CON
HAD IMPROVED; FUNCTION WAS REGAINED IN THE LOWER EXTREMITIES. THE FIELD STAFF HAD INDICATED IN 2008, THAT THE
IT WAS REPORTED THAT HE PT HAD RECEIVED SPINAL ANESTHESIA PRIOR TO SYSTEM PLACEMENT. SUBSEQUENTLY, THE PT DE
BOTH LEAD PRODUCTS WERE EXPLANTED. RESULTS OF MRI EXAM OF THE BRAIN AND SPINAL CORD HAD REVEALED NO ABNO
PT WAS AMBULATORY AGAIN. THE PHYSICIAN HAD INDICATED TO THE FIELD STAFF THAT THE CONDITION HAD BEEN A CONVE
IT WAS REPORTED THAT THE PT HAD RECEIVED SPINAL ANESTHESIA PRIOR TO SYSTEM PLACEMENT. SUBSEQUENTLY, THE PT D
BOTH LEAD PRODUCTS WERE EXPLANTED. RESULTS OF MRI EXAM OF THE BRAIN AND SPINAL CORD HAD REVEALED NO ABNO
PT WAS AMBULATORY PAIN. THE PHYSICIAN HAD INDICATED TO THE FIELD STAFF THAT THE CONDITION HAD BEEN A CONVERS
THE PT UNDERWENT A NEUROSTIMULATION TRIAL PROCEDURE WITHOUT COMPLICATIONS. THE DAY AFTER THE PROCEDURE
THE EXACT LOCATION AND AMOUNT OF BLOOD WAS NOT REPORTED. SOME LOWER LEVEL PARALYSIS WAS REPORTED, BUT N
THE SPINE THAT WAS RELATED TO BLEEDING. THE PT REMAINED HOSPITALIZED FOR THREE DAYS, THE PT'S PAIN HAD IMPROVE
WEAKNESS AND NO SENSORY CHANGES". REFER TO MFR REPORT #6000153200802198. .
. THE PT UNDERWENT A NEUROSTIMULATION TRIAL PROCEDURE WITHOUT COMPLICATIONS. THE DAY AFTER THE PROCEDUR
THE EXACT LOCATION AND AMOUNT OF BLOOD WAS NOT REPORTED. SOME LOWER LEVEL PARALYSIS WAS REPORTED, BUT N
THE SPINE THAT WAS RELATED TO BLEEDING. THE PT REMAINED HOSPITALIZED FOR THREE DAYS, THE PT'S PAIN HAD IMPROVE
WEAKNESS AND NO SENSORY CHANGES". REFER TO MFR REPORT #6000153200802199.
THE PT WAS IMPLANTED WITH AN IPG AND LEAD FOR SCS IN 2008. THE PT WAS ABLE TO WALK OUT OF THE HOSPITAL THE VE
INCISION WAS. THE NEXT DAY, THE SURGEON NOTIFIED THE ANS SALES REPRESENTATIVE THAT THE PT WAS NOW COMPLAININ
SPINAL CANAL AND COMPRESSED THE CORD. THE SURGEON PERFORMED A LAMINECTOMY TO REMOVE THE LEAD AND DECO
RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. ALL RECORDS WERE REVIEWED AND WERE FOUND TO M
DISCOLORATION IN THE PADDLE BUT NO OTHER ANOMALIES. ANS INC HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HIST
IT WAS REPORTED THAT THE PT HAD A NEUROSTIMULATOR IMPLANTED FOR PAIN. THE STIMULATOR WAS INITIALLY SUCCESSF
WAS WALKING WHEN HE ENTERED THE HOSP, BUT WAS IN A WHEELCHAIR WHEN HE WAS RELEASED AND SUFFERING FROM L
THE PT WAS IMPLANTED WITH AN IPG AND LEAD FOR SCS IN 2007. IT WAS REPORTED THAT POST-OPERATIVELY THE PT DID NO
EXPLORATORY SURGERY. THE PHYSICIAN COULD NOT VISIBLY SEE A HEMATOMA AND THE SCS SYSTEM WAS LEFT IMPLANTED.
STILL UNABLE TO FEEL HIS LEGS AND HE SUBSEQUENTLY ALSO DEVELOPED AN INFECTION. THE PT'S SCS SYSTEM WAS EXPLANT
WALK, BUT HE IS ABLE TO STAND WITH THE ASSISTANCE OF A WALKER. EVAL METHOD: ADDITIONALLY, DEVICE HISTORY RECOR
SPECIFICATIONS. ANS INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION
THE EXPLANTED PRODUCTS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. SHO
SURGEON DISCOVERED AND TREATED A HEMATOMA. THE PATIENT'S TRIAL LEADS WERE EXPLANTED. THE PATIENT HAS REPOR
THE EXPLANTED PRODUCTS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. SHO
PHYSICIAN ALSO DISCOVERED AND EVACUATED A HEMATOMA. THE PT IS CURRENTLY HOSPITALIZED.
SHORTLY AFTER IMPLANT, THE PT REPORTED PARALYSIS AND WAS ADMITTED TO THE HOSP. THE PHYSICIAN EXPLANTED THE S
. THE REPRESENTATIVE REPORTED IMPLANT OF THE SURGICAL LEAD; THE TOP OF THE SCS LEAD WAS AT T9 AND GOOD BILATE
TO T9; THE SYSTEM WAS TURNED OFF. THE PT SYMPTOMS WERE BILATERAL PARALYSIS FROM THIGHS TO TOES. IMPEDANCE R
. IN 2001, THE PATIENT WAS DIAGNOSED WITH REFLEX SYMPATHETIC DYSTROPHY (RSD) WITH CRPS, TYPE 1, THAT WAS CAUSE
CORD STIMULATOR SYSTEM TO TREAT RSD IN THE RIGHT ARM WITH THE LEADS PLACED IN THE CERVICAL AREA. THE PATIENT D
A REHABILITATION FACILITY. THE PATIENT'S CASE WORKER AT THE REHABILITATION FACILITY REPORTED THE THERAPY WORKED
INITIALLY WITH A "PARKINSONIAN TYPE GAIT," IT WAS A WIDE-BASED GAIT WITH SOME DEGREE OF COG WHEELING, OR STUT
EXAMINED THE PATIENT AND FOUND NOTHING WRONG NEUROLOGICALLY. THE PATIENT EXHIBITED AN UNUSUAL GAIT PATTER
DETERMINED THE PROBLEMS WERE PROBABLY PSYCHOLOGICAL. THE PATIENT WAS REFERRED TO A PSYCHOLOGIST FOR FURTH
REPROGRAMMED THE DEVICE IN 2003 WITH NO DIFFERENCE IN THE ATAXIA OR THE STIMULATION TO THE ARM. INITIALLY TH
NOT MAKE A DIFFERENCE WHETHER THE PRODUCT WAS ON OR OFF. THE PATIENT UNDERWENT A SERIES OF COGNIZANT BEH
SCAN REVEALED THE LEAD HAD MIGRATED LATERALLY; SOME MILD COMPRESSION OF THE DORSAL ROOTLET WAS NOTED, BUT
CEREBELLUM. THE HCP RECOMMENDED THE ELECTRODE BE REMOVED BECAUSE IT WASN'T PROVIDING ADEQUATE PAIN RELIE
THE RIGHT ARM. LATER, THE SYSTEM WAS EXPLANTED WITH NO COMPLICATIONS NOTED DURING THE REMOVAL SURGERY. TH
SPINAL CORD STIMULATOR SYSTEM. THE PHYSICIAN DID NOT KNOW THE FINAL DEVICE DISPOSITION AFTER EXPLANT. IN 2007
THE RIGHT LOWER EXTREMITY, AS WELL AS THE UPPER RIGHT EXTREMITY. THE PATIENT HAS LIMITED ABILITY TO TOLERATE STA
THE PATIENT IS ABLE TO PERFORM HER OWN HYGIENE NEEDS AND IS ABLE TO DO ASPECTS OF MEAL PREPARATION AND HOUS
ALLODYNIA OF THE RIGHT ARM AND RIGHT LEG. THE PATIENT HAS SPASTIC WEAKNESS OF THE RIGHT LEG AND EDEMA IN THE
INITIALLY; SHE HAS MORE HYPERSENSITIVITY IN THE LEG AND A MORE ATAXIC, UNCOORDINATED PATTERN TO IT. HER CURREN
WALKS ALONG THE WALL FOR SUPPORT. THE PATIENT IS ABLE TO TOLERATE RIDING AN EXERCYCLE 20 MINUTES A DAY. HER ATA
6000032200400888.
THE LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. DURING A LEAD REVI
SO THE DOCTOR EXPLANTED ONE LEAD AND STOPPED THE PROCEDURE. THE NEXT DAY, THE PATIENT REPORTED PARALYSIS AN
SHE IS NO LONGER EXPERIENCING PARALYSIS, BUT STILL HAS MINOR WEAKNESS IN THE RIGHT LEG.
METHOD: DEVICE HISTORY RECORD INCLUDING THE STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE R
MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. MFR DEFERS TO THE PT'S PHYSICIA
THE SAME AFTERNOON, TO DO AN MRI AND NOW THE PT IS PARALYZED. ANS ATTEMPTED TO OBTAIN ADD'L INFO REGARDING
ANALYSIS. FOLLOW-UP ON THE PT FOUND THAT HE IS AT A REHABILITATION HOSPITAL AND STILL HAS SOME PARALYSIS.
DURING A LEAD REVISION PROCEDURE, THE PT EXPERIENCED PAIN AND JUMPED, HITTING A SURGICAL TOOL. THE PT REPORTE
SHE HAD A BURNING SENSATION AROUND HER SPINAL CORD. THE PT'S SYSTEM WAS EXPLANTED.
THE MFR REP REPORTED A HEMATOMA LOCATED AROUND THE LEAD FOUR DAYS POST-IMPLANT. THE PT WAS RUSHED TO THE
PERFORMED WHICH REVEALED DECOMPRESSIVE LAMINECTOMY. THE PT CURRENTLY HAS MOVEMENT IN THE RIGHT LEG; THE
CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR FOLLOW-UP REPORT WILL BE SENT TO FDA IF
THE MANUFACTURER REPRESENTATIVE REPORTED A HEMATOMA LOCATED AROUND THE LEAD FOUR DAYS POST-IMPLANT. TH
THE HEMATOMA. A MRI WAS PERFORMED WHICH REVEALED DECOMPRESSIVE LAMINECTOMY. THE PATIENT CURRENTLY HAS
INFORMATION HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EV
6000153-2007-01157.
PRELIMINARY DEVICE EVAL WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN AD
THE REPORT PROVIDED BY THE REP INDICATES THE PT EXPERIENCED A POST-OPERATIVE BLOOD CLOT LOCATED ABOVE THE LEA
COMPLICATIONS OF REPORTED NUMBNESS AND PARALYSIS IN THE LEGS AND WAS UNABLE TO WALK FOLLOWING PLACEMEN
REALIZED TOTAL DEVICE SYSTEM EXP AND THE BLOOD CLOT ITSELF WAS REMOVED. THE REP REPORTED ON 2/13/07 THE STATU
AGAIN. THE DEVICE WAS EXPLANTED AND HAS BEEN RETURNED TO THE MFR FOR EVAL. ADD'L INFO HAS BEEN REQUESTED FR
AFTER AN ATTEMPT TO PLACE A TRIAL LEAD, THE PT WAS HOSPITALIZED DUE TO A HEMATOMA AND PARALYSIS.
MANUFACTURER REPRESENTATIVE REPORTS A PATIENT IMPLANTED WITH A SURGICAL LEAD FOR RIGHT ARM PAIN DEVELOPED
PAIN IN THE RIGHT ARM AS A COMPLICATION OF SURGERY. A NEW LEAD AND GENERATOR WERE PLACED ON 9/20/06 AND TH
RECEIVING BENEFIT IN THE RIGHT ARM. THE PATIENT WILL BE TRANSFERRED TO A LONG TERM CARE FACILITY FOR REHABILITA
MANUFACTURER REPRESENTATIVE REPORTS A PATIENT WHO HAD JUST UNDERGONE PLACEMENT OF A NEUROSTIMULATOR E
NOT MOVE THE RIGHT LEG. THE PATIENT WAS TAKEN BACK TO SURGERY LATER THAT NIGHT, TO REMOVE THE ENTIRE SYSTEM.
MANUFACTURER REPRESENTATIVE REPORTS A PATIENT EXHIBITING LEFT SIDE PARALYSIS AFTER REMOVAL OF A TRIAL STIMULA
WEEK LATER, THE PATIENT RETURNED FOR REMOVAL OF THE TRIAL SYSTEM AFTER A SUCCESSFUL TRIAL. THE PATIENT UNDERW
IN THE NECK, WHILE SHOWERING AND WEAKNESS IN THE LEFT ARM AND LEG. THE PATIENT WAS ADMITTED TO THE ER AND W
LATER, THE PATIENT STATUS WAS IMPROVING. THE PATIENT WAS OFF THE VENTILIZER, WITH LEFT LEG MOBILITY AND SENSATI
HCP REPORTS PATIENT PRESENTED IN THE EMERGENCY ROOM WITH PARALYSIS OF BOTH LEGS. PATIENT UNDRWENT TOTAL D
PATIENT WAS ABLE TO MOVE TOES AND DOSE FEEL PAIN. PATIENT LEFT THE HOSPITAL AGAINST MEDICAL ADVICE. THE HCP NO
ADDITIONAL INFORMATION VIA OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: SPINAL CORD STIMULATOR IN PLACE WITH O
EXTREMITY WEAKNESS AND NUMBNESS 6 DAYS OUT FROM INSERTION ON SPINAL CORD STIMULATOR PADDLE THROUGH LAM
RESTROOM AND WENT BACK TO BED AND HAD NUMBNESS AND WEAKNESS ONSET AND WAS BROUGHT TO THE HOSPITAL. DE
THORACIC REGION OPENING THE OLD INCISION AND DISSECTING DOWN THE FASCIA. HCP STATES THERE WAS NO SUBFASCIAL
MANUFACTURER REPRESENTATIVE REPORTED THE DEVICE WAS EXPLANTED DUE TO A BACTERIAL INFECTION AFTER STAGE ON
LOWER BODY PARALYSIS. THE DEVICE WAS EXPLANTED, BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.
ATTORNEY REPORTS " A NEUROSTIMULATOR, INCLUDING A MODEL 7427 IPG, 3487A LEADS, AND 7489-25 EXTENSTIONS WERE
MONTHS LATER, THAT SHE CONTINUED TO COMPLAIN OF PAIN FOLLOWING THE IMLPANTS, THAT SHE EXPERIENCED SEVERAL
BECAUSE THEY "WERE PLACED SO CLOSE TO THE SPINAL CORD THAT NOT ALL OF THE LEADS COULD BE SAFELY REMOVED WIT
ATTORNEY REPORTS "A NEUROSTIMULATOR, INCLUDING A MODEL 7427 IPG, 3487A LEADS, AND 7489-25 EXTENSIONS WERE I
MONTHS LATER. SHE CONTINUED TO COMPLAIN OF PAIN FOLLOWING THE IMPLANTS, AND EXPERIENCED SEVERAL COMPLICA
"WERE PLACED SO CLOSE TO THE SPINAL CORD THAT NOT ALL OF THE LEADS COULD BE SAFELY REMOVED WITHOUT RISK OF P
HCP REPORTS FOLLOWING THE REVISION OF THE PT'S STIMULATOR, THE PT EXPERIENCED TEMPORARY PARALYSIS OF THE ARM
BY MODIFYING THE SETTINGS OF THE IPG, CHANGES IN PHARMACOTHERAPY, AND DOING PSYCHOTHERAPY. THE HCP REPORTS
FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONA
NOTIFICATION THAT THIS EVENT DOES NOT MEET THE USER FACILITYS REPORTING CRITERIA WILL BE FILEVALUATION SUMMAR
THE HCP REPORTED THAT THE PT HAD UNDERGONE SEVERAL YEARS OF GASTRIC ELECTROSTIMULATOR FOR GASTRIC PARESIS
FROM THE TOP OF THE GASTRIC ELECTROSTIMULATOR SITE. EXAMINATION OF THE POCKET SITE REVEALED PURULENCE MATE
AREA PACKED WITH LOOSE GAUZE AND STERILE DRESSINGS. EXAMINATION OF THE DEVICE REVEALED THE IPG TO BE FUNCTIO
MFR REP REPORTED PT HAD NEUROSTIMULATOR IMPLANT. POST SURGERY PT HAD DECREASED RIGHT LEG MOVEMENT, HOW
WENT TO ICU. THE REP REPORTED THE PT IS CURRENTLY ON THE REHABILIATION FLOOR FOR PARALYSIS. THE DEVICES WERE E
LEAD AND IPG WAS REMOVED. NEUROSURGERY CONSULT. INPATIENT REHABILITATION COURSE. PT CONTINUES TO HAVE RIGH
H6: PRELIMINARY DEVICE ANALYSIS RESULTS WERE NOT AVAILABLE ON THE DATE OF THIS REPORT. MFR REPRESENTATIVE REPO
REMOVED LEAD. MFR REPRESENTATIVE REPORTED PT IS CURRENTLY ABLE TO MOVE BOTH LEGS. THE DEVICE WAS EXPLANTED
MANUFACTURER REPRESENTATIVE REPORTED PARALYSIS AFTER SURGERY. HCP REPORTED A CLOT WAS FORMED AFTER SURGE
APPROXIMATELY 6 AMPS. THE ASSISTANT FIDDLED WITH THE CONNECTOR WHILE THE AMPS WERE STILL UP. THE PT EXPERIEN
WAS EXPLANTED OR RETURNED TO THE MFR FOR ANALYSIS. IT IS UNCLEAR WHAT DEVICES WERE INVOLVED.
MANUFACTURER EMPLOYEE REPORTED EPIDURAL HEMATOMA AFTER IMPLANTATION OF SPECIFY LEAD. MANUFACTURER REP
T12. THE PATIENT DEVELOPED A NEW SEVERE BACKACHE AT OR NEAR THE LEAD SITE. THE PATIENT WENT TO THE HOSPITAL/ER
EPIDURAL HEMATOMA. THE DOCTOR HAD DIFFICULTY EVACUATING ALL OF IT AND/OR CONTROLLING ONGOING EPIDURAL BLE
AND TO PREVENT POTENTIAL PARALYSIS. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MFR FOR ANALYSIS. A FOL
THE PT WAS HAVING SURGERY FOR LOWER EXTREMITY PAIN. A VERSITREL STIMULATOR AND LEAD WERE TO BE IMPLANTED. W
AND IPG WERE NOT IMPLANTED--THE SURGERY WAS ABORTED. THREE MRIS WERE PERFORMED. THE RESULTS WERE NEGATIV
1998 WAS THE DATE OF THE SPINAL STIMULATOR SURGERY WITH A PELVIC PAIN PT WHICH WAS AN ATTEMPTED LUMBAR AND
PAIN PT, WITH A NEUROMED DUAL OCTRODE TRIAL SPINAL CORD STIMULATING CATHETER SYSTEM MANUFACTURED BY ADVA
NO N7354 X03. A DURAL TEAR AND/OR PUNCTURE OCCURRED WITH SINAL FLUID LEAKAGE, A SPINAL HEADACHE, PHOTOPHO
SURGICALY UNTIL APPROXIMATELY 10 DAYS AFTER. WITH STIMULATION, THE PAIN GOT WORSE IN THE LEGS AND BUTTOCKS A
ARACHNOIDITIS IS ALSO KNOWN TO SHORTEN THE LIFESPAN OF THE ARACHNOIDITIS SUFFERER BY APPROXIMATELY 12 YEARS
AND 3 LEVELS. IT ALSO INCLUDES NERVE ROOTS WITHIN THE THECAL SAC APPEARING TO BE SOMEWHAT ADHESED WITH LESS
A MANUFACTURER REPRESENTATIVE REPORTED A PT WITH BILATERAL PARALYSIS AND AN EPIDURAL HEMATOMA. IN 2002 THE
TIME. THE PT WAS DISCHARGED AND INSTRUCTED TO RETURN TO THE CLINIC FOR PROGRAMMING THE NEXT WEEK. THE PT W
EXCISED THE HEMATOMA RELIEVING THE PRESSURE ON THE EPIDURAL SPACE. THE DEVICE IS STILL IMPLANTED. THE PT IS PRE
REPORT RECEIVED OF COMPLICATIONS DURING STIMULATION TRIAL PROCEDURE. PATIENT NOW HAS SOME PARALYSIS. IT WA
SECURE ADDITIONAL INFORMATION. A FOLLOW UP MEDWATCH REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS R
PT HAD REVISION OF LEADS IN 2002 WITH USE OF LEAD MODEL 3998. PT PARALYSIS WAS REPORTED POST OP. FOLLOW UP WI
PROCEDURE WAS UNEVENTFUL WITH EASY INSERTION OF THE PADDLE LEAD. EXPLANT OF DEVICE AT THIS TIME WAS RULED O
HAS NOT BEEN PROVIDING ANY STIMULATION EFFECT SO PT STILL HAS PAIN.
HCP REPORTED THAT "PT WAS NOT ABLE TO FEEL LEFT SIDE POST SURGERY." NO REPORT OF DEVICE EXPLANTATION. A FOLLOW
IMPLANT. HE HAD NO FEELING OR MOBILITY ON THE AFFECTED SIDE. CONDITION HAS IMPROVED - LEGS MUCH IMPROVED - W
UP WITH HCP REVEALED - PT HAD SEVERE PARALYSIS AT THE TIME OF THE IMPLANT. HE HAD NO FEELING OR MOBILITY ON TH
EXTREMITY. DEVICE REMAINS IMPLANTED AND PROVIDING THERAPY.
THE PT UNDERWENT IMPLANTATION OF NEUROSTIMULATION LEADS FOR PARKINSON'S DISEASE. DURING THE PROCEDURE, TH
LEAD PLACEMENT IN THE SUBTHALAMIC NUCLEUS. APPROXIMATELY TWO HRS POSTOPERATIVELY, THE PT BECAME UNAROUSA
THE PT WAS HOSPITALIZED IN THE NEURO INTENSIVE CARE UNIT. THE HCP STATED THE PT'S CONDITION IS UNCHANGED AND P
THE PT UNDERWENT IMPLANTATION OF AN ITREL NEUROSTIMULATION SYSTEM IN 1999 FOR CHRONIC INTRACTABLE PAIN OF
INSTRUCTIONS ON HOW TO PROPERLY AND SAFELY IMPLANT THE LEAD AND THE IPG. AS A DIRECT AND PROXIMATE RESULT O
PARALYSIS OF THE LEFT LEG, HAND AND FINGERS, LOSS OF THE USE OF THEIR LEFT ARM, NUMBNESS ON THE RIGHT SIDE OF T
PT WAS IMPLANTED WITH A SPINAL CORD STIMULATOR FOR FAILED BACK SURGERY SYNDROME ON 11/20/1998. ON 11/22/19
ABSORBED. THE PT RECOVERED WITH PHYSICAL THERAPY. THE PHYSICIAN FELT THE SYMPTOMS MAY HAVE BEEN DUE TO A CO
PT WAS IMPLANTED WITHOUT ANY DIFFICULTY WITH LEAD AT ABOUT 6 PM AT T10-T11. NO COMPLAINTS OF PROBLEMS AT IM
REPORTS FEELING AND MOVEMENT HAS RETURNED TO LOWER LEGS AND UPPER LEGS REMAIN SLIGHTLY NUMB. H-6 DEVICE N
PT WAS IMPLANTED WITHOUT ANY DIFFICULTY WITH LEAD AT ABOUT 6 PM AT T10-T11. NO COMPLAINTS OF PROBLEMS AT IM
REPORTS FEELING AND MOVEMENT HAS RETURNED TO LOWER LEGS AND UPPER LEGS REMAIN SLIGHTLY NUMB. H-6 DEVICE N
REPORT RECEIVED FROM PT'S RELATIVE STATES THAT PT EXPERIENCED PARALYSIS AFTER IMPLANTATION OF STIMULATION SYST
PT EXPERIENCED INCONTINENCE, BLADDER INFECTION, AND A REAPPEARANCE OF THE PARALYSIS. INVESTIGATION INTO THIS M
THIS LETTER WILL SERVE TO INITIATE A COMPLAINT WITH THE FDA AGAINST MEDTRONIC FOR MISBRANDING AND FAILURE TO
INCLUDING THE RESUME LEAD. BY NOT LISTING ASYMPTOMATIC STENOSIS AS A CONTRAINDICATION IN ITS LABELING NOR WA
SPACE OR WARNING PHYSICIANS TO INSERT THE RESUME 3586 LEAD BY LAMINECTOMY AS OPPOSED TO LAMINOTOMY, MEDT
BACK TO AT LEAST 1982 WHEN MEDTRONIC WAS INVOLVED IN A LAWSUIT." THE FAILURE OF MEDTRONIC TO WARN IMPLANTI
PARALYSIS WITHOUT A "DEAR DOCTOR" LETTER OR OTHER ACTION BEING TAKEN AS SOON AS POSSIBLE.
LITIGANT HAD NEUROSTIMULATION SYSTEM IMPLANTED, AND REQUIRED AN ADD'L SURGERY TO CORRECT MIGRATION OF LEA
CAUSING UPPER AND LOWER EXTREMITY INJURY, PARALYSIS, AND NUMBNESS."

SCS - Paralysis Reports Thru May 2019

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Primary word(s) count

spinal paralysis 681

7575109 2017-05-18 2018-06-04 2018-06-06 2018-06-06 Malfunction

7431114 2017-12-11 2018-03-20 2018-04-13 2018-04-13 Death

6868327 2016-01-19 2017-09-13 2017-09-14 Injury

6433225 2017-02-24 2017-02-24 2017-02-24 2017-03-24 Injury

5588535 2016-03-23 2016-04-28 2016-03-25 2016-04-20 Death

5317969 2015-12-02 2015-12-02 2015-12-22 Injury

5276952 2015-12-01 2015-12-06 2015-12-06 Injury

4255889 2015-01-27 2014-10-27 2014-11-17 Injury

3931353 2014-06-30 2014-06-30 2014-07-14 Injury

3301315 2013-10-04 2013-07-24 2013-08-21 Injury

3301327 2013-10-04 2013-07-24 2013-08-21 Injury

2185457 2011-06-01 2015-05-29 2011-06-19 2011-07-12 Injury

1400814 2006-01-25 2006-01-26 2006-01-26 2009-06-11 Injury

8650298 2019-05-09 2019-05-10 2019-05-29 2019-05-29 Injury

8629886 2019-04-23 2019-04-23 2019-05-21 2019-05-21 Injury

8613809 2019-04-03 2019-04-17 2019-05-15 2019-05-15 Injury

8608530 2019-06-04 2019-06-06 2019-05-14 Injury

8608897 2019-03-28 2019-04-16 2019-05-14 2019-05-14 Injury

8584193 2019-03-25 2019-04-17 2019-05-06 2019-05-06 Injury

8579019 2019-04-11 2019-04-11 2019-05-03 2019-05-03 Injury

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8458613 2019-02-28 2019-02-28 2019-03-27 2019-03-27 Injury

8444569 2019-02-15 2019-03-05 2019-03-22 2019-03-22 Injury

8343953 2019-02-13 2019-02-13 2019-02-15 2019-02-15 Malfunction

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7938994 2018-09-30 2018-10-10 2018-10-25 2018-10-05 Malfunction

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7904288 2018-08-25 2018-08-27 2018-09-24 2018-09-24 Injury

7897653 2018-09-20 2018-09-21 2018-09-28 2018-09-21 Injury

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7674653 2018-06-14 2018-07-10 2018-07-10 Injury

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7671043 2018-06-09 2018-06-11 2018-07-09 2018-07-09 Injury

7663824 2018-06-04 2018-06-08 2018-07-05 2018-07-05 Injury

7635019 2018-06-01 2018-06-21 2018-06-25 2018-06-25 Malfunction

7558456 2018-05-01 2018-05-10 2018-05-31 2018-05-31 Injury

7548951 2018-05-01 2018-05-24 2018-05-29 2018-05-29 Malfunction

7534428 2018-04-07 2018-04-23 2018-05-22 2018-05-22 Injury

7522263 2018-05-15 2018-05-17 2018-05-22 2018-05-17 Malfunction

7505276 2018-04-13 2018-04-13 2018-05-10 2018-05-10 Injury

7502488 2018-05-09 2018-05-09